Browse Device Recalls
1,515 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,515 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 1,515 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. cannula, surgic... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Orthopedic manu... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Arthroscope. | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Screw, fixation... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Spinal interlam... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Apr 1, 2016 | Various trauma and sports medicine instruments and implants. Rod, fixation, ... | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... | Class II | Biomet, Inc. |
| Mar 9, 2016 | All instrumentation associated with the Prelude PF Resurfacing Knee System. | Inadequate design control. | Class II | Biomet, Inc. |
| Feb 16, 2016 | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retrac... | Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retract... | Class II | Biomet, Inc. |
| Feb 16, 2016 | HipLOC CHS Plate/Lag Screw Introducer | A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not... | Class II | Biomet, Inc. |
| Feb 12, 2016 | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Mod... | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mi... | Class II | Biomet Spine, LLC |
| Feb 12, 2016 | Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stab... | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... | Class II | Zimmer Spine, Inc. |
| Feb 12, 2016 | Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or mo... | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... | Class II | Zimmer Spine, Inc. |
| Feb 11, 2016 | M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prost... | Class II | Zimmer Biomet, Inc. |
| Feb 5, 2016 | Vanguard XP Knee System Porous Femoral Component various sizes and orientat... | The anterior/posterior (AP) dimension may be oversized by 0.016. If the femoral component does... | Class II | Biomet, Inc. |
| Feb 3, 2016 | Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipi... | Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fix... | Class II | Zimmer Spine, Inc. |
| Jan 29, 2016 | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets includi... | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in sur... | Class II | Biomet, Inc. |
| Jan 21, 2016 | Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, ... | Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 month... | Class II | Biomet France SARL |
| Jan 20, 2016 | Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotac... | Complaints were received reporting the system would freeze/shut down while in Fulgurate mode. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-const... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constr... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, c... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femo... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained,... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, ceme... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotib... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads N... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, pate... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous unce... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 11, 2016 | NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat ... | LDPE bag containing the implant adheres to the highly polished implant surface. | Class II | Zimmer Biomet, Inc. |
| Jan 5, 2016 | Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Inst... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usa... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Pro... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usa... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usa... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usag... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Produc... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Produ... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instrum... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
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.