Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceC.R. Bard IncClass IICatalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
There is potential for packaging defects that may impact the sterile barrier.
- 2021-09-29FDA-DeviceNorth American Rescue LLC.Class II10 ga ARS Decompression Needle, Part Number ZZ-0298
The device includes the incorrect Instructions for Use.
- 2021-09-29FDA-DeviceConvaTec, IncClass IIDuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
There is a potential for open seals which can compromise sterility.
- 2021-09-29FDA-DeviceSIGHT DIAGNOSTICS LTDClass IISight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM; NO189
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION XF TIBIA CEMENTED T5 RM; NO161Z AS UNIVATION XF TIBIA CEMENTED T6 RM; NO162Z AS UNIVATION XF TIBIA CEMENTED T1 LM; NO163Z AS UNIVATION XF TIBIA CEMENTED T2 LM; NO164Z AS UNIVATION XF TIBIA CEMENTED T3 LM; NO165
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F MENISCAL COMP.T5 RM/LM 11MM NL499 UNIVATION F MENISCAL COMP.T6 RM/LM 11MM
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION F MENISCAL COMP.T5 RM/LM 10MM; NL493 UNIVATION F MENISCAL COMP.T6 RM/LM 10MM
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F MENISCAL COMP.T5 RM/LM 9MM; NL487 UNIVATION F MENISCAL COMP.T6 RM/LM 9MM
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F MENISCAL COMP.T2 RM/LM 8MM; NL478 UNIVATION F MENISCAL COMP.T3 RM/LM 8MM; NL479 UNIVATION F MENISCAL COMP.T4 RM/LM 8MM; NL480 UNIVATION F MENISCAL COMP.T5 RM/LM 8MM; NL481 UNIVATION F MENISCAL COMP.T6 RM/LM 8MM
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceAesculap Implant Systems LLCClass IIUnivation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
Malfunction- loosening of the implant resulting in a potential revision surgery
- 2021-09-29FDA-DeviceBeckman Coulter Inc.Class IIAccess SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
- 2021-09-29FDA-DeviceGreiner Bio-One North America, Inc.Class IIGreiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
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