Lot Numbers: Y8739, Y8296, Y7619, Y7004, Y5966 and Y3169.

Physical Medicine Devices

1

No

Nationwide Distribution

Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" || Model: 72108

Serial number ranges: RRFK00036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRFK00254; RRFK00256-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; RRJK0001; RRIK00003; RRIK00004; RRFK00234; RRFK00236; RRFK00285; RRFK00286; and RRJK00002

Physical Medicine Devices

2

No

Worldwide Distribution - USA Nationwide, United Kingdom, Germany, and Saudi Arabia

RotoProne Therapy System, Model 209500, Device List Number E232632 || Product is designed to allow patients to be mechanically rotated to the prone position and provides kinetic therapy to patients. It is intended for the treatment and prevention of pulmonary complications associated with immobility.

Recalled chairs include the following Models : Recalled chairs include the following:   2008 Model Numbers:  653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner.   2009 Model Numbers:  6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.  Recalled model numbers are as folows:  6530-02, 6530-03, 6530-03-TB, 6530-04, 6530-06, 6530-07, 6530-08, 6530-08-TB-00-PB, 6530-14, 6530-15, 6530-15-00-00-00-00-LC, 6530-15-00-00-PB, 6530-16, 6530-17, 6530-17-TB, 6530-25, 65302N,  65302NT,  6530-30, 6530-31, 6530-33, 6530-37-00-00-PB, 6530-39, 6530-39-00-00-PB, 65303N,  65303N,  65304N,  65304NH,  65304NHT,  65304NT,  6530-63, 6530-63-TB, 65306N,  65306NH,  65307N,  65307NT,  65308N,  65308NT,  65314N,  65314NH,  65314NT,  65315N,  65316N,  65317N,  65317NT,  65330N,  65333NT,  65337N,  65341N,  65344N,  65360N,  65361N,  65362N,  65362NT,  65363N,  65363NT,  6540-02, 6540-03, 6540-04, 6540-04-00-HM, 6540-06, 6540-07, 6540-08, 6540-14, 6540-16-TB, 6540-17, 6540-17-TB, 65402N,  65402NT,  6540-30-00-00-PB, 6540-37, 6540-39, 6540-39-00-00-PB, 65403N,  65403NT,  65404N,  65404NH,  65404NHT,  6540-60, 6540-63-TB, 65406N,  65406NH,  65407N,  65408N,  65414N,  65414NT,  65415N,  65416N,  65417N,  65417NT,  65430N,  65437N,  65441N,  65442N,  65461NH,  65462N,  65465N,  6550-02, 6550-03, 6550-03-00-HM, 6550-04, 6550-06, 6550-13, 6550-14, 6550-14-00-00-PB, 6550-14-00-HM, 6550-16, 6550-17, 65502N,  6550-30-00-HM, 6550-34-00-00-PB, 6550-37, 6550-39-00-HM, 65503N,  65503NH,  65504N,  65504NL,  65504NT,  65504NT-DART,  65506N,  65506NH,  65507N,  65507NH,  65508N,  65514N,  65514NH,  65514NL,  65514NW,  65515N,  65516N,  65516NH,  65516NT,  65517N,  65517NCE,  65517NH,  65517NHT,  65525N,  65527N,  65527NH,  65528NH,  65530NH,  65532N,  65532NH,  65533N,  65537N,  65539N,  65539NH,  65541NL,  65544NW,  65561NL,  65562NH,  65562NL,  65567N,  65567NH,  6570-02, 6570-03, 6570-03-00-HM, 6570-07, 6570-14, 6570-14-00-00-PB, 6570-14-00-HM, 6570-17, 6570-17-00-00-PB, 6570-17-00-00-PC, 6570-17-TB,  65702N,  65702NT,  6570-39-00-HM,  65703N,  65703NH,  6570-41,  65704N,  65704NT,  6570-62, 6570-63-TB,  65706N ,  65706NH,  65707N,  65707NH,  65708N,  65708NT,  65714N,  65714NH,  65714NL,  65714NT,  65714NW,  65715N,  65716NH,  65717N,  65717NCE,  65717NH,  65725N,  65727NH,  65728NH,  65730N,  65730NH,  65732N,  65732NH,  65733N,  65737N,  65739N,  65739NH,  65741NH,  65741NL,  65761N,  65762N,  65762NH,  65762NL,  65763NH,  65766N,  65767NH,  6900-02, 6900-03, 6900-04, 6900-17, 69002N ,  6900-30, 6900-39 ,  69003N,  69003NH,  6900-41,  69004N,  6900-60, 6900-61, 6900-62, 6900-63, 6900-63-00-HM, 6900-63-TB,  69006N,  69007N,  69008N,  69008NH,  69014N,  69014NT,  69014NW,  69015N,  69016N,  69016NT,  69017N,  69017NH,  69026N,  69027N,  69028N,  69030N,  69030NH,  69031N,  69032N,  69033N,  69034N,  69037N,  69039N,  69041N,  69041NH,  69060N,  69062N,  69063N,  69063NH,  69063NT,  69065NT,  69066N,  69066NT,  69067N,  6910-03, 6910-06, 6910-17, 6910-32, 6910-33-00-HM, 6910-37-00-00-PB, 6910-37-TB, 6910-39,  69103N,  69104N,  6910-60, 6910-61, 6910-62, 6910-63,  69106N,  69107NT,  69114N,  69114NW,  69117N,  69117NH,  69117NT,  69127N,  69133N,  69133NT,  69134N,  69137N,  69162N,  69163N,  69167N,  6940-03, 6940-03-00-HT, 6940-04-TB-HT, 6940-06, 6940-06-TB-HM, 6940-07-TB, 6940-14, 6940-14-TB, 6940-15, 6940-15-00-HM, 6940-16, 6940-16-TB-HM, 6940-17, 6940-17-00-HM, 6940-17-TB-HM, 6940-19-TB-HM, 6940-26-TB, 6940-26-TB-HM, 6940-27-TB-HM, 69402N,  69402NT,  6940-30, 6940-32, 6940-32-TB, 6940-33-TB-HM,  69403N,  69403NH,  69403NT,  69403NW,  6940-41-TB-HM,  69404N,  69404NDH,  69404NH,  69404NHT,  69404NT,  69404NWT,  6940-60-TB-HT, 6940-62, 6940-62-TB, 6940-62-TB-HM, 6940-62-TB-HT, 6940-63-TB, 69406N,  69406NH,  69407N ,  69407NT,  69414N,  69414NH,  69414NT,  69415N,  69415NH,  69415NHT,  69416N,  69416NHT,  69416NT,  69417N,  69417NHT,  69417NT,  69417NW,  69419NHT,  69427NHT,  69429NT,  69430NH,  69432N,  69432NT,  69433N,  69433NH,  69433NHT,  69433NT,  69434N,  69434NHT,  69437NH,  69437NHT,  69441NHT,  69444ND,  69444NDH,  69460N,  69460NHT,  69460NWT,  69461NH,  69462N,  69462NHT,  69462NT,  69463N,  69463NH,  69463NT,  69463NWT,  69466NWT,  69467N,  6950-03, 6950-03-00-HT, 6950-04-00-HM, 6950-04-TB-HT, 6950-06-TB-HM, 6950-15, 6950-16-TB-HM, 6950-19-TB-HM, 6950-19-TB-HT, 6950-26-TB-HM, 6950-27-TB-HM, 69502NH,  6950-33, 6950-33-TB-HM, 6950-39-00-HM,  69503N,  69503N,  69503NH,  69503NT,  6950-41-00-HT,  69504N,  69504NH,  69504NW,  6950-60, 6950-60-TB-HT, 6950-62-00-00-PB, 6950-62-TB-HT, 69506NHT,  69514N,  69514NH,  69514NHT,  69514NT,  69515N,  69515NH,  69516N,  69516NHT,  69516NT,  69517N,  69517NH,  69517NHT,  69517NT,  69519NHT,  69527NHT,  69529NT,  69530NH,  69532N,  69532NT,  69533N,  69533NH,  69533NHT,  69534N,  69541NHT,  69544ND,  69560N,  69560NHT,  69560NWT,  69561N,  69561NH,  69562N,  69562NHT,  69563NH,  69563NWT.

Physical Medicine Devices

1

No

Worldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.

Recalled chairs include the following: || 2008 Model Numbers: || 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, || 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. || 2009 Model Numbers: || 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.

Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.

Physical Medicine Devices

2

No

Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.

Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD

All serial numbers

Physical Medicine Devices

2

No

Nationwide Canada

Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.

Physical Medicine Devices

1

No

Nationwide Distribution

Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. || Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

Serial numbers: 200803001, 200803002, 200803003, 200803004, 200803005, 200803006, 200803007, 200803008, and 200803009.

Physical Medicine Devices

1

No

The product was only distributed within the US by the US company. Any OUS distribution was handled by the manufacturer in Germany.

Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15 . 37115 Duderstadt /Germany. || Pediatric Prosthetic Device used by Lower Limb amputees.

Lot Numbers: Y3356 and Y3170.

Physical Medicine Devices

1

No

Nationwide Distribution

Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" || Model: 72109

Product number BL120M, with the letters, ''SPS'' etched into the product

Physical Medicine Devices

1

No

Nationwide

SPS Blue Line Tube Clamp Adapters, Product No. BL120M

NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405

Physical Medicine Devices

3

No

Nationwide

CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).

Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.

Physical Medicine Devices

Unclassified

No

Nationwide Distribution.

Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.

Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD,  E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA,  E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA,  E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC,  E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE,  E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA,  E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA,  E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC,  E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD,  E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA,  E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB,  E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair.

Physical Medicine Devices

1

No

Worldwide Distribution including USA and countries of Spain and Great Britain.

Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. || The product is used as a hip strap chair for children.

Model: , Affected: Reuseable ATAR multiple lots

Physical Medicine Devices

Physical Medicine Devices

Physical Medicine Devices

md

Physical Medicine Devices

Physical Medicine Devices

Press release: Safety alert on ShoulderFlex massager

Physical Medicine Devices

Medical Device Safety Alert: ATAR Extension Cable

Physical Medicine Devices

Medical electronics / Electromedical devices - electrotherapy

Model Number: viz FSN

Physical Medicine Devices

Medical devices for single use

Model Catalog: BREEZE C4 (Lot serial: >100 contact manufacturer); Model Catalog: BREEZE C3 (Lot serial: >100 contact manufacturer)

Physical Medicine Devices

BREEZE C4 MOBILITY SCOOTER

Model Catalog: ATAR D-R 1 (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDT (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-V (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-R D2P (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-A (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-R (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDTR (Lot serial: > THAN 10 CONTACT MFR); Model Catalog: ATAR D-MDT2 (Lot serial: > THAN 10 CONTACT MFR)

Physical Medicine Devices

ATAR DISPOSABLE EXTENSION CABLES

T2100 and T2000 Treadmill power cords ARTG number: 118412

Physical Medicine Devices

Invacare TDX series and Storm Series power wheelchairs with 20”-24” width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style backModels:TDX Series: TDXSP, TDXSP-AUS, TDX SR-AUS & TDX SRStorm Series: 3GTQ-MCG, STORM TORQUE, STORM TORQUE-AUS, RANGERX, 3GRX-CG, ARROW 3G & 3GAR-TSMultiple serial numbersManufactured from October 1, 2006 - July 31, 2014ARTG number: 160385

Physical Medicine Devices

Physical Medicine Devices

Alert extension cable wires - dark