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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,125 FDA device recalls.

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DateProductReasonClassFirm
Apr 28, 2017 FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM ... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 13... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L ... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 28, 2017 FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX... Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single pac... Class II Zimmer Biomet, Inc.
Apr 26, 2017 Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The ... Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Bas... Class II Zimmer Biomet, Inc.
Apr 25, 2017 Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotatin... A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requ... Class II Zimmer Biomet, Inc.
Apr 17, 2017 AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is ... nail not properly engaging with the targeting jig due to certain undersized specification Class II Zimmer Biomet, Inc.
Apr 13, 2017 Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gent... Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek pac... Class II Zimmer Biomet, Inc.
Apr 12, 2017 Bone Dowell Harvest Tubes mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously subst... Class II Zimmer Biomet, Inc.
Mar 22, 2017 Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM... pegs shearing post-operatively Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 18x250mm bwd, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and acces... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and ac... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 16x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, se... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary a... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and acce... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and ac... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, met... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 18x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/po... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessor... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and acc... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/... Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 28, 2017 Por fullct fem st 17x200mm, Sterile, Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged ... Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning an... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 27, 2017 MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning ... Unapproved change made by the supplier. Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Custom parts Product Usage: Custom Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.
Feb 17, 2017 various polyethylene implants Extremities, Shoulders and Elbows BioModular... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.