Rheo 2 Item Number: RKN120007  Serial #s affected:  323056 321498

Physical Medicine Devices

2

No

Worldwide distribution: US distribution in TN and country of: Austria.

The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.

Model: 1424, System number 50-HC-1424, Batch number 2-1301 and GM-0314.

Physical Medicine Devices

1

No

US nationwide distribution to AL, CA, FL, HI, IL, KY, KS, LA, MI, NY, OK, OR, PA, SC, TX, VA, VT and WV.

AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.

All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136

Physical Medicine Devices

1

No

US Distribution to the states of : FL, CA, NJ, NC and MD.

ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.

Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038

Physical Medicine Devices

2

No

Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.

Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)

Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038

Physical Medicine Devices

2

No

Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.

Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)

Physical Medicine Devices

1

No

Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

GE Healthcare, Treadmill T2100. || For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

Serial numbers higher than 224017

Physical Medicine Devices

1

No

Nationwide Distribution including GA, CT and PA.

Etac Supporter toilet armrest || Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.

All lot numbers

Physical Medicine Devices

1

No

Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.

Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : || CooperSurgical || PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; || PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and || Fisher Brand. || PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; || PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX

Model #AIRPTMBDY18, Serial #s: 12JSZD60025, 12JSZD60026, 12JSZD60027, 12KSZD60001, 12KSZD60002, 12KSZD60004, 12KSZD60005, 12KSZD60006, 12KSZD60007, 12KSZD60008, 12KSZD60010, 12KSZD60013, 12KSZD60014, 12KSZD60015, 12KSZD60016, 12KSZD60017, 12KSZD60018, 12KSZD60019, 12KSZD60020, 12KSZD60021, 12KSZD60022, 12KSZD60023, 12KSZD60024, 12KSZD60026, 12KSZD60028, 12KSZD60029, 12KSZD60030, 12KSZD60031, 12KSZD60032, 12KSZD60033, 12KSZD60034, 12KSZD60035, 12KSZD60036, 12KSZD60037, 12KSZD60038, 12KSZD60039, 12KSZD60040, 12KSZD60041, 12KSZD60042, 12KSZD60043, 12KSZD60045, 12KSZD60046, 12KSZD60047, 12KSZD60048, 12KSZD60049, 12KSZD60050, 12KSZD60051, 12KSZD60052, 12KSZD60053, 12KSZD60054, 12KSZD60055, 12KSZD60056, 12KSZD60057, 12KSZD60058, 12KSZD60059, 12KSZD60060, 12KSZD60061, 12KSZD60063, 12KSZD60064, 12KSZD60065, 12KSZD60066, 12KSZD60067, 12KSZD60069, 12KSZD60070, 12KSZD60071, 12KSZD60072, 12KSZD60073, 12KSZD60075, 12KSZD60076, 12KSZD60077, 12KSZD60078, 12KSZD60079, 12KSZD60080, 12KSZD60081, 12KSZD60082, 12KSZD60083, 12KSZD60085, 12KSZD60086, 12KSZD60087, 12KSZD60088, 12KSZD60091, 12KSZD60092, 12KSZD60093, 12KSZD60094, 12KSZD60095, 12KSZD60096, 12KSZD60098, 12KSZD60099, 12KSZD60100, 12KSZD60101, 12KSZD60103, 12KSZD60105, 12KSZD60107, 12KSZD60108, 12KSZD60109, 12KSZD60110, 12KSZD60111, 12KSZD60112, 12KSZD60114, 12KSZD60115, 12KSZD60116, 12KSZD60117, 12KSZD60118, 12KSZD60120, 12KSZD60121, 12KSZD60122, 12KSZD60123, 12KSZD60124, 12KSZD60125, 12KSZD60126, 12KSZD60127, 12KSZD60128, 12KSZD60129, 12KSZD60130, 12KSZD60131, 12KSZD60134, 12KSZD60136, 12KSZD60137, 12KSZD60138, 12KSZD60139, 12KSZD60140, 12KSZD60141, 12KSZD60142, 12KSZD60143, 12KSZD60144, 12KSZD60145, 12KSZD60146, 12KSZD60147, 12KSZD60148, 12KSZD60149, 12KSZD60151, 12KSZD60152, 12KSZD60153, 12KSZD60154, 12KSZD60155, 12KSZD60156, 12KSZD60158, 12KSZD60159, 12KSZD60160, 12KSZD60162, 12KSZD60163, 12KSZD60164, 12KSZD60165, 12KSZD60166, 12KSZD60168, 12KSZD60169, 12KSZD60170, 12KSZD60171, 12KSZD60172, 12KSZD60173, 12KSZD60174, 12KSZD60176, 12KSZD60177, 12KSZD60178, 12KSZD60179, 12KSZD60180, 12KSZD60181, 12KSZD60182, 12KSZD60183, 12KSZD60186, 12KSZD60187, 12KSZD60188, 12KSZD60189, 12KSZD60190, 12KSZD60191, 12KSZD60192, 12KSZD60193, 12KSZD60194, 12KSZD60195, 12KSZD60197, 12KSZD60198, 12KSZD60199, 12KSZD60200, 12KSZD60201, 12KSZD60203, 12KSZD60204, 12KSZD60205, 12KSZD60206, 12KSZD60207, 12KSZD60209, 12KSZD60211, 12KSZD60212, 12KSZD60213, 12KSZD60214, 12KSZD60215, 12KSZD60216, 12KSZD60217, 12KSZD60219, 12KSZD60220, 12LSZD60001, 12LSZD60002, 12LSZD60003, 12LSZD60004, 12LSZD60006, 12LSZD60007, 12LSZD60008, 12LSZD60009, 12LSZD60011, 12LSZD60012, 12LSZD60014, 12LSZD60015, 12LSZD60017, 12LSZD60018, 12LSZD60020, 12LSZD60021, 12LSZD60024, 12LSZD60025, 12LSZD60026, 12LSZD60027, 12LSZD60028, 12LSZD60029, 12LSZD60030, 12LSZD60031, 12LSZD60032, 12LSZD60033, 12LSZD60034, 12LSZD60035, 12LSZD60036, 12LSZD60037, 12LSZD60040, 12LSZD60042, 12LSZD60043,12LSZD60044, 12LSZD60046, 12LSZD60047, 12LSZD60048, 12LSZD60049, 12LSZD60050, 12LSZD60051, 12LSZD60052, 12LSZD60053, 12LSZD60054,12LSZD60055, 12LSZD60056, 12LSZD60058, 12LSZD60059, 12LSZD60063, 12LSZD60064, 12LSZD60067, 12LSZD60068, 12LSZD60069, 12LSZD60070, 12LSZD60071, 12LSZD60072, 12LSZD60073, 12LSZD60074, 12LSZD60075, 12LSZD60076, 12LSZD60077, 12LSZD60078, 12LSZD60079, 12LSZD60080, 12LSZD60081, 12LSZD60083, 12LSZD60084, 12LSZD60085, 12LSZD60086, 12LSZD60088, 12LSZD60089, 12LSZD60091, 12LSZD60093, 12LSZD60094, 12LSZD60095, 12LSZD60096, 12LSZD60097, 12LSZD60098, 12LSZD60099, 12LSZD60100, 12LSZD60101, 12LSZD60102, 12LSZD60103, 12LSZD60104, 12LSZD60105, 12LSZD60107, 12LSZD60109, 12LSZD60110, 12LSZD60112, 12LSZD60113, 12LSZD60114, 12LSZD60115, 12LSZD60116, 12LSZD60117, 12LSZD60121, 12LSZD60122, 12LSZD60123, 12LSZD60124, 12LSZD60126, 12LSZD60127, 12LSZD60128, 12LSZD60129, 12LSZD60130, 12LSZD60131, 12LSZD60132, 12LSZD60134, 12LSZD60135, 12LSZD60136, 12LSZD60137, 12LSZD60139, 12LSZD60140, 12LSZD60141, 12LSZD60142, 12LSZD60144, 12LSZD60145, 12LSZD60146, 12LSZD60147, 12LSZD60149, 12LSZD60150, 12LSZD60151, 12LSZD60152, 12LSZD60155, 12LSZD60156, 12LSZD60158, 12LSZD60159, 12LSZD60160, 12LSZD60161, 12LSZD60162, 12LSZD60163, 12LSZD60164, 12LSZD60167, 12LSZD60168, 12LSZD60169, 12LSZD60170, 12LSZD60171, 12LSZD60172, 12LSZD60173, 12LSZD60174, 12LSZD60175, 12LSZD60176, 12LSZD60177, 12LSZD60178, 12LSZD60181, 12LSZD60182, 12LSZD60185, 12LSZD60187, 12LSZD60190, 12LSZD60192, 12LSZD60193, 12LSZD60194, 12LSZD60195, 12LSZD60197, 12LSZD60198, 12LSZD60199, 12LSZD60200, 12LSZD60201, 12LSZD60202, 12LSZD60203, 12LSZD60205, 12LSZD60206, 12LSZD60207, 12LSZD60208, 12LSZD60209, 12LSZD60210, 12LSZD60211, 12LSZD60212, 12LSZD60213, 12LSZD60214, 12LSZD60215, 12LSZD60216, 13CSZD60001, 13CSZD60002, 13CSZD60003, 13CSZD60004, 13CSZD60005, 13CSZD60006, 13CSZD60008, 13CSZD60009, 13CSZD60011, 13CSZD60013, 13CSZD60015, 13CSZD60016, 13CSZD60018, 13CSZD60019, 13CSZD60022, 13CSZD60023, 13CSZD60024, 13CSZD60025, 13CSZD60026, 13CSZD60028, 13CSZD60029, 13CSZD60031, 13CSZD60032, 13CSZD60034, 13CSZD60035, 13CSZD60036, 13CSZD60037, 13CSZD60039, 13CSZD60040, 13CSZD60041, 13CSZD60042, 13CSZD60044, 13CSZD60045, 13CSZD60046, 13CSZD60047, 13CSZD60048, 13CSZD60050, 13CSZD60051, 13CSZD60052, 13CSZD60054, 13CSZD60055, 13CSZD60056, 13CSZD60057, 13CSZD60058, 13CSZD60059, 13CSZD60066, 13CSZD60071, 13CSZD60072, 13CSZD60074, 13CSZD60075, 13CSZD60076, 13CSZD60077, 13CSZD60078, 13CSZD60079, 13CSZD60080, 13CSZD60082, 13CSZD60083, 13CSZD60084, 13CSZD60085, 13CSZD60087, 13CSZD60088, 13CSZD60091, 13CSZD60093, 13CSZD60095, 13CSZD60097, 13CSZD60098, 13CSZD60099, 13CSZD60100, 13CSZD60101, 13CSZD60102, 13CSZD60103, 13CSZD60104, 13CSZD60105, 13CSZD60107, 13CSZD60108, 13CSZD60110, 13CSZD60112, 13CSZD60113, 13CSZD60114, 13CSZD60115, 13CSZD60116, 13CSZD60117, 13CSZD60118, 13CSZD60119, 13CSZD60128, 13CSZD60130, 13CSZD60131, 13CSZD60133, 13CSZD60134, 13CSZD60135, 13CSZD60136, 13CSZD60138, 13CSZD60140, 13CSZD60141, 13CSZD60144, 13CSZD60146, 13CSZD60147, 13CSZD60148, 13CSZD60149, 13CSZD60150, 13CSZD60151, 13CSZD60153, 13CSZD60154, 13CSZD60155, 13CSZD60156, 13CSZD60157, 13CSZD60159, 13CSZD60163, 13CSZD60164, 13CSZD60166, 13CSZD60167, 13CSZD60168, 13CSZD60170, 13CSZD60171, 13CSZD60173, 13CSZD60175, 13CSZD60178, 13CSZD60180, 13CSZD60182, 13CSZD60183, 13CSZD60188, 13CSZD60189, 13CSZD60191, 13CSZD60193, 13CSZD60194, 13CSZD60198. 13CSZD60199, 13CSZD60200, 13CSZD60201, 13CSZD60203, 13CSZD60204, 13CSZD60205, 13CSZD60207, 13CSZD60208, 13CSZD60211, 13CSZD60213, 13CSZD60214, 13CSZD60215, 13CSZD60216, 13CSZD60219, 13CSZD60224, 13CSZD60225, 13CSZD60227, 13CSZD60229, 13DSZD60001, 13DSZD60002, 13DSZD60003, 13DSZD60004, 13DSZD60005, 13DSZD60007, 13DSZD60008, 13DSZD60010, 13DSZD60012, 13DSZD60013, 13DSZD60015, 13DSZD60016, 13DSZD60017, 13DSZD60019, 13DSZD60020, 13DSZD60021, 13DSZD60023, 13DSZD60024, 13DSZD60026, 13DSZD60027, 13DSZD60029, 13DSZD60030, 13DSZD60032, 13DSZD60033, 13DSZD60034, 13DSZD60035, 13DSZD60036, 13DSZD60037, 13DSZD60039, 13DSZD60040, 13DSZD60041, 13DSZD60042, 13DSZD60043, 13DSZD60044, 13DSZD60045, 13DSZD60046, 13DSZD60047, 13DSZD60055, 13DSZD60056, 13DSZD60057, 13DSZD60058, 13DSZD60059, 13DSZD60060, 13DSZD60061, 13DSZD60062, 13DSZD60065, 13DSZD60066, 13DSZD60067, 13DSZD60068, 13DSZD60069, 13DSZD60074, 13DSZD60075, 13DSZD60076, 13DSZD60077, 13DSZD60078, 13DSZD60079, 13DSZD60080, 13DSZD60081, 13DSZD60082, 13DSZD60084, 13DSZD60085, 13DSZD60086, 13DSZD60087, 13DSZD60088, 13DSZD60089, 13DSZD60091, 13DSZD60092, 13DSZD60095, 13DSZD60096, 13DSZD60097, 13DSZD60098, 13DSZD60099, 13DSZD60100, 13DSZD60101, 13DSZD60102, 13DSZD60103, 13DSZD60104, 13DSZD60105, 13DSZD60107, 13DSZD60108, 13DSZD60109, 13DSZD60110, 13ESZD60002, 13ESZD60003, 13ESZD60004, 13ESZD60005, 13ESZD60007, 13ESZD60008, 13ESZD60009, 13ESZD60010, 13ESZD60011l, 13ESZD60012, 13ESZD60014, 13ESZD60015, 13ESZD60016, 13ESZD60017, 13ESZD60018, 13ESZD60019, 13ESZD60020, 13ESZD60021, 13ESZD60022, 13ESZD60023, 13ESZD60024, 13ESZD60025, 13ESZD60027, 13ESZD60030, 13ESZD60031, 13ESZD60032, 13ESZD60033, 13ESZD60034, 13ESZD60035.13ESZD60036, 13ESZD60037, 13ESZD60038, 13ESZD60039, 13ESZD60040, 13ESZD60041, 13FSZD60001, 13FSZD60002, 13FSZD60003, 13FSZD60004, 13FSZD60005, 13FSZD60006, 13FSZD60009, 13FSZD60011, 13FSZD60012, 13FSZD60013, 13FSZD60014, 13FSZD60015, 13FSZD60016, 13FSZD60017, 13FSZD60018, 13FSZD60019, 13FSZD60020, 13FSZD60021, 13FSZD60022, 13FSZD60023, 13FSZD60024, 13FSZD60025, 13FSZD60027, 13FSZD60030, 13FSZD60031, 13FSZD60032, 13FSZD60033, 13FSZD60034, 13FSZD60035, 13FSZD60036, 13FSZD60037, 13FSZD60040, 13FSZD60041, 13FSZD60042, 13FSZD60043, 13FSZD60044, 13FSZD60045, 13FSZD60048, 13FSZD60049, 13FSZD60050, 13FSZD60051, 13FSZD60052, 13FSZD60053,13FSZD60054, 13FSZD60055, 13FSZD60056, 13FSZD60057, 13FSZD60058, 13FSZD60060, 13FSZD60061, 13FSZD60062, 13FSZD60063, 13FSZD60064, 13FSZD60067, 13FSZD60068, 13FSZD60069, 13FSZD60070, 13FSZD60071, 13FSZD60072, 13FSZD60075, 13FSZD60076, 13FSZD60078, 13FSZD60079, 13FSZD60080, 13FSZD60081, 13FSZD60082, 13FSZD60084, 13FSZD60085, 13FSZD60086, 13FSZD60088, 13FSZD60089, 13FSZD60094, 13FSZD60096, 13FSZD60097, 13FSZD60098, 13FSZD60100, 13FSZD60101, 13FSZD60102,13FSZD60103, 13FSZD60104, 13FSZD60106, 13FSZD60107, 13FSZD60111, 13FSZD60112, 13FSZD60114, 13FSZD60115, 13FSZD60118, 13FSZD60119, 13FSZD60120, 13FSZD60121, 13GSZD60001, 13GSZD60003, 13GSZD60004, 13GSZD60006, 13GSZD60007, 13GSZD60010, 13GSZD60011, 13GSZD60013, 13GSZD60014, 13GSZD60015, 13GSZD60016, 13GSZD60017, 13GSZD60018, 13GSZD60019, 13GSZD60022, 13GSZD60023, 13GSZD60024, 13GSZD60025, 13GSZD60026, 13GSZD60027, 13GSZD60030, 13GSZD60031, 13GSZD60032, 13GSZD60033, 13GSZD60036, 13GSZD60037, 13GSZD60038, 13GSZD60040, 13GSZD60042, 13GSZD60043, 13GSZD60045, 13GSZD60046, 13GSZD60048, 13HSZD60004, 13HSZD60005, 13HSZD60006, 13HSZD60007, 13HSZD60009, 13HSZD60010, 13HSZD60011, 13HSZD60013, 13HSZD60014, 13HSZD60015, 13HSZD60017, 13JSZD60002, 13JSZD60004, 13JSZD60010, 13JSZD60011, 13JSZD60013, 13JSZD60014, 13JSZD60015, 13JSZD60017, 13JSZD60018, 13JSZD60019, 13JSZD60020, 13JSZD60021, 13JSZD60023, 13JSZD60026, 13JSZD60034, 13JSZD60035, 13JSZD60037, 13JSZD60038, 13JSZD60039, 13JSZD60040, 13JSZD60041, 13JSZD60043, 13JSZD60045, 13JSZD60046, 13JSZD60047, 13JSZD60048, 13JSZD60049, 13JSZD60050, 13JSZD60051, 13JSZD60052, 13JSZD60053, 13JSZD60054, 13JSZD60055, 13JSZD60058, 13JSZD60060, 13JSZD60061, 13JSZD60063, 13JSZD60064, 13JSZD60065, 13JSZD60067, 13JSZD60069, 13JSZD60071, 13JSZD60074, 13JSZD60076, 13JSZD60077, 13JSZD60078, 13JSZD60079, 13JSZD60080, 14ESZD60005, 14ESZD60007, 14ESZD60008, 14ESZD60015, 14ESZD60016, 14ESZD60020, 14ESZD60021, 14ESZD60023, 14ESZD60024, 14ESZD60025, 14ESZD60038, 14ESZD60039, 14ESZD60044,14ESZD60057, 14ESZD60058, 14ESZD60061, 14ESZD60062, 14ESZD60063, 14ESZD60067, 14ESZD60069, 14ESZD60070, 14ESZD60071, 14ESZD60075, 14ESZD60076, 14ESZD60078, 14ESZD60080, 14ESZD60082, 14ESZD60087, 14ESZD60089, 14ESZD60090, 14ESZD60092, 14ESZD60093, 14ESZD60094, 14ESZD60096, 14ESZD60101, 14ESZD60103, 14ESZD60104, 14ESZD60105, 14ESZD60106, 14ESZD60108, 14ESZD60109, 14ESZD60111, 14ESZD60112, 14ESZD60113 & 14ESZD60114.  Model #AIRPTMBDY20, Serial #s: 12KSZD60009, 12KSZD60025, 12KSZD60084, 12KSZD60097, 12KSZD60104, 12KSZD60132, 12KSZD60135, 12KSZD60150, 12LSZD60016, 12LSZD60045, 12LSZD60061, 12LSZD60065, 12LSZD60082, 12LSZD60087, 12LSZD60111, 12LSZD60119, 12LSZD60143, 12LSZD60148, 12LSZD60153, 13CSZD60021, 13CSZD60049, 13CSZD60060, 13CSZD60106, 13CSZD60111, 13CSZD60123, 13CSZD60129, 13CSZD60142, 13CSZD60158, 13CSZD60192, 13CSZD60202, 13CSZD60210, 13DSZD60004, 13DSZD60006, 13DSZD60011, 13DSZD60022, 13DSZD60038, 13DSZD60050, 13DSZD60051, 13DSZD60052, 13DSZD60054, 13ESZD60001, 13ESZD60013, 13ESZD60026, 13FSZD60007, 13FSZD60026, 13FSZD60029, 13FSZD60077, 13FSZD60091, 13FSZD60092, 13FSZD60095, 13FSZD60099, 13GSZD60029, 13GSZD60044, 13HSZD60012, 13HSZD60016, 13JSZD60024, 13JSZD60033, 13JSZD60044, 13JSZD60056, 13JSZD60066, 14ESZD60017, 14ESZD60018, 14ESZD60027, 14ESZD60037, 14ESZD60040, 14ESZD60077, 14ESZD60081, 14ESZD60083 & 14ESZD60084.  Model #AIRPTBASE, Serial #s: 12KSZD60068, 12KSZD60119, 12LSZD60106, 12LSZD60166, 12LSZD60180, 13CSZD60092, 13DSZD60063, 13DSZD60064, 13DSZD60090, 13FSZD60008, 13FSZD60028, 13FSZD60046, 13FSZD60047, 13HSZD60001, 13JSZD60001, 13JSZD60068, 14ESZD60014, 14ESZD60022, 14ESZD60065, 14ESZD60068, 14ESZD60072, 14ESZD60074, 14ESZD60086, 14ESZD60088, 14ESZD60091, 14ESZD60097, 14ESZD60098, 14ESZD60102 & 14ESZD60107.

Physical Medicine Devices

2

No

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO

Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

The affected products are individually identified within the serial number range: 1-425 regarding Art No. 81703030, 1-205 regarding Art No. 81703050, All distributed regarding Art No. 81703080

Physical Medicine Devices

1

No

Nationwide Distribution including FL, AZ, and CA.

Etac Relax wall mounted shower seat || The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.

The removal affects all devices manufactured and distributed since February 2014.

Physical Medicine Devices

1

No

Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.

Ottobock Pheon 3R62 Knee Joint || The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.

Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X

Physical Medicine Devices

1

No

Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.

Covidien Argyle Infant Heel Warmers (no tab) || Item Code: MH00002N || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling

Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X

Physical Medicine Devices

1

No

Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.

Covidien Argyle Infant Heel Warmers (with tab) || Item Code: MH00002T || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.

Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.

Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. || Provide mobility to persons limited to a sitting position.

Model EIZ4-2, serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928.

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.

Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. || Provide mobility to persons limited to a sitting position.

Serial Numbers: 1030000887 1030000931 1030000934 1030000993 1030001039 1030001057 1030001059 1030001173 1030001182 1030001210 1030001226 1030001254 1030001292 1030001315 1030001318 1030001358 1030001371 1030001441 1030001460 1030001526 1030001528 1030001568 1030001640 1030001641 1030001710 1030001720 1030001743 1030001797 1030001807 1030001819 1030002013 1030002025 1030002051 1030002129 1030002185 1030002214 1030002225 1030002233 1030002252 1030002316 1030002331 1030002406 1030002413 1030002444 1030002458 1030002489 1030002524 1030002534 1030002582 1030002601 1030002622 1030002626 1030002638 1030002669 1030002673 1030002689 1030002690 1030002715 1030002736 1030002755 1030002764 1030002881 1030002886 1030002889 1030002890 1030002904 1030002905 1030002924 1030002942 1030002946 1030002947 1030002969 1030002975 1030003005 1030003013 1030003015 1030003044 1030003077 1030003098 1030003143 1030003186 1030003284 1030003308 1030003314 1030003316 1030003392 1030003413 1030003423 1030003428 1030003435 1030003454 1030003457 1030003494 1030003535 1030003560 1030003562 1030003584 1030003650 1030003675 1030003732 1030003734 1030003755 1030003792 1030003804 1030003807 1030003817 1030003856 1030003858 1030003859 1030003861 1030003862 1030003880 1030003951 1030003959 1030003983 1030003985 1030003987 1030003988 1030003994 1030004012 1030004014 1030004018 1030004025 1030004027 1030004071 1030004072 1030004085 1030004091 1030004108 1030004113 1030004118 1030004126 1030004127 1030004134 1030004138 1030004185 1030004203 1030004205 1030004223 1030004225 1030004236 1030004242 1030004250 1030004256 1030004262 1030004270 1030004276 1030004278 1030004292 1030004293 1030004294 1030004297 1030004300 1030004310 1030004311 1030004326 1030004327 1030004339 1030004343 1030004351 1030004385 1030004387 1030004403 1030004413 1030004415 1030004418 1030004424 1030004425 1030004428 1030004430 1030004436 1030004441 1030004444 1030004456 1030004457 1030004463 1030004474 1030004480 1030004481 1030004484 1030004486 1030004493 1030004495 1030004510 1030004513 1030004517 1030004518 1030004526 1030004534 1030004536 1030004539 1030004540 1030004544 1030004550 1030004552 1030004556 1030004562 1030004569 1030004579 1030004584 1030004585 1030004590 1030004608 1030004610 1030004619 1030004623 1030004634 1030004639 1030004679 1030004690 1030004702 1030004704 1030004708 1030004711 1030004713 1030004718 1030004719 1030004720 1030004722 1030004724 1030004726 1030004735 1030004736 1030004738 1030004744 1030004747 1030004751 1030004772 1030004779 1030004786 1030004790 1030004800 1030004801 1030004802 1030004806 1030004808 1030004810 1030004814 1030004821 1030004829 1030004842 1030004848 1030004852 1030004854 1030004858 1030004868 1030004869 1030004873 1030004875 1030004878 1030004889 1030004893 1030004897 1030004898 1030004908 1030004909 1030004913 1030004915 1030004918 1030004930 1030004931 1030004941 1030004945 1030004968 1030004971 1030004980 1030004990 1030004993 1030004998 1030005003 1030005006 1030005007 1030005015 1030005018 1030005019 1030005030 1030005033 1030005034 1030005037 1030005038 1030005041 1030005062 1030005063 1030005065 1030005068 1030005086 1030005099 1030005115 1030005116 1030005121 1030005123 1030005124 1030005125 1030005126 1030005136 1030005143 1030005146 1030005147 1030005157 1030005167 1030005169 1030005183 1030005186 1030005199 1030005206 1030005207 1030005213 1030005222 1030005223 1030005231 1030005239 1030005243 1030005246 1030005263 1030005266 1030005269 1030005271 1030005273 1030005274 1030005284 1030005292 1030005298 1030005305 1030005312 1030005317 1030005320 1030005324 1030005328 1030005332 1030005337 1030005340 1030005350 1030005351 1030005357 1030005366 1030005376 1030005379 1030005381 1030005385 1030005386 1030005398 1030005401 1030005408 1030005422 1030005428 1030005430 1030005431 1030005436 1030005443 1030005445 1030005446 1030005452 1030005463 1030005468 1030005469 1030005478 1030005481 1030005484 1030005485 1030005488 1030005489 1030005491 1030005493 1030005494 1030005515 1030005522 1030005530 1030005535 1030005536 1030005538 1030005542 1030005546 1030005550 1030005560 1030005570 1030005572 1030005573 1030005574 1030005577 1030005584 1030005602 1030005607 1030005608 1030005609 1030005610 1030005613 1030005621 1030005635 1030005637 1030005648 1030005650 1030005665 1030005666 1030005667 1030005669 1030005723 1030005724 1030005731 1030005732 1030005735 1030005737 1030005740 1030005744 1030005754 1030005755 1030005757 1030005761 1030005765 1030005766 1030005776 1030005779 1030005786 1030005794 1030005800 1030005805 1030005829 1030005843 1030005846 1030005848 1030005870 1030005883 1030005904 1030005905 1030005916 1030005918 1030005920 1030005921 1030005932 1030005945 1030005946 1030005952 1030005958 1030005961 1030005979 1030006007 1030006011 1030006012 1030006025 1030006028 1030006037 1030006040 1030006043 1030006047 1030006053 1030006058 1030006059 1030006062 1030006067 1030006068 1030006070 1030006085 1030006088 1030006095 1030006099 1030006107 1030006113 1030006114 1030006116 1030006120 1030006138 1030006139 1030006145 1030006149 1030006156 1030006160 1030006171 1030006174 1030006176 1030006181 1030006185 1030006188 1030006191 1030006192 1030006194 1030006199 1030006204 1030006206 1030006209 1030006210 1030006213 1030006220 1030006223 1030006242 1030006243 1030006244 1030006250 1030006255 1030006268 1030006271 1030006272 1030006274 1030006279 1030006288 1030006296 1030006297 1030006308 1030006323 1030006327 1030006339 1030006345 1030006346 1030006354 1030006361 1030006373 1030006400 1030006404 1030006407 1030006410 1030006421 1030006434 1030006436 1030006457 1030006462 1030006469 1030006474 1030006484 1030006522 1030006524 1030006596 1030006616 1030006621 1030006667 1030006669 1030006674 1030006679 1030006684 1030006685 1030006697 1030006720 1030006724 1030006736 1030006738 1030006746 1030006751 1030006752 1030006754 1030006767 1030006776 1030006789 1030006808 1030006830 1030006840 1030006851 1030006868 1030006874 1030006878 1030006882 1030006887 1030006888 1030006895 1030006901 1030006905 1030006908 1030006909 1030006944 1030006945 1030006954 1030006958 1030006965 1030006966 1030006975 1030006978 1030006982 1030006983 1030006985 1030006987 1030007007 1030007008 1030007017 1030007043 1030007060 1030007061 1030007075 1030007083 1030007089 1030007091 1030007094 1030007095 1030007098 1030007109 1030007118 1030007127 1030007137 1030007141 1030007149 1030007164 1030007182 1030007183 1030007188 1030007195 1030007197 1030007198 1030007207 1030007210 1030007219 1030007224 1030007235 1030007241 1030007242 1030007250 1030007267 1030007278 1030007281 1030007284 1030007291 1030007306 1030007327 1030007346 1030007348 1030007375 1030007381 1030007390 1030007401 1030007411 1030007415 1030007422 1030007430 1030007431 1030007432 1030007436 1030007438 1030007442 1030007448 1030007472 1030007476 1030007484 1030007490 1030007492 1030007500 1030007502 1030007526 1030007542 1030007568 1030007570 1030007580 1030007620 1030007635 1030007637 1030007641 1030007657 1030007659 1030007664 1030007708 1030007713 1030007726 1030007739 1030007746 1030007755 1030007758 1030007761 1030007766 1030007795 1030007813 1030007818 1030007826 1030007832 1030007844 1030007850 1030007861 1030007864 1030007878 1030007941 1030007943 1030007985 1030007998 1030008004 1030008007 1030008013 1030008024 1030008168 1030008220 1030008227 1030008234 1030008248 1030008266 1030008287 1030008291 1030008292 1030008293 1030008295 1030008296 1030008298 1030008311 1030008318 1030008324 1030008331 1030008338 1030008350 1030008359 1030008372 1030008383 1030008410 1030008411 1030008418 1030008420 1030008451 1030008452 1030008467 1030008470 1030008473 1030008487 1030008493 1030008511 1030008514 1030008528 1030008531 1030008537 1030008545 1030008553 1030008567 1030008576 1030008597 1030008623 1030008630 1030008640 1030008652 1030008671 1030008682 1030008691 1030008736 1030008743 1030008745 1030008751 1030008754 1030008760 1030008762 1030008778 1030008818 1030008823 1030008834 1030008836 1030008845 1030008866 1030008873 1030008897 1030008901 1030008914 1030008918 1030008928 1030008931 1030008933 1030008949 1030008952 1030008953 1030008959 1030008979 1030008980 1030009013 1030009041 1030009051 1030009055 1030009057 1030009067 1030009077 1030009137 1030009138 1030009148 1030009154 1030009171 1030009181 1030009184 1030009199 1030009311 1030009317 1030009348 1030009518 1030009541 1030009542 1030011281 1030012359, and  1030012658.

Physical Medicine Devices

2

No

Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TX, UT, VA, VT, WA, and WI.

Philips GoSafe Mobile Help Button; 7000MHB. || Personal Emergency Response System.

Model #: 02200002  All units received from the manufacture prior to the week of July 12, 2015

Physical Medicine Devices

2

No

Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia

Monode, Shortwave Accessory || Model #: 02200002 || Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

Serial Numbers: H006, H007, H019, H020, H021, H022, H023, H024. Note: serial numbers may be written with an additional leading 0 (e.g. H0024 instead of H024)

Physical Medicine Devices

2

No

Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.

Robotic hand accessory to InMotion Arm, rehabilitation robot.

All product in distribution

Physical Medicine Devices

1

No

Moberly, MO

Cardinal Health Tiny Toes; 11470-010T Infant heel warmer

(1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

Corflex Contender Post-Op Knee Brace Lite || Model: 75-7500-000 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

(1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

ADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE || Model: 75-7500-231 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

(1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE || Model : 75-7500-038 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

(1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015

Physical Medicine Devices

1

No

Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.

CONTENDER POST-OP-KNEE BRACE FULL FOAM || Model: 75-7550-000 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

All serviced between 27 April 2015 and 17 November 2015

Physical Medicine Devices

1

No

Nationwide Distribution.

Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.

Item #  935-0245H6 Flexx (KM852216) Serial #  TM14-A03982-TM14-A03991  Item # 935-0246H6 Flexx (KM852218) Serial #  TM14-A03992-TM14-A04012  Item # 935-0247H6 Flexx (KM852220) Serial #  TM14-A4013-TM14-A04017

Physical Medicine Devices

1

No

U.S. distribution to the following states -- WA, CA, NY, and TX.

Karma Flexx Wheelchair || Manual Wheelchair.