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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.

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DateProductReasonClassFirm
Sep 30, 2025 Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with... Incorrect titanium screw, packaged with dental implant. Class II Prismatik Dentalcraft, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 26, 2025 Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm ... Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit... Class II Zimmer, Inc.
Sep 23, 2025 BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Numbe... There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint... Class II Biomet, Inc.
Sep 9, 2025 Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products withi... Class II Biomet, Inc.
Apr 2, 2025 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... Due to manufacturing issues, abutment products were manufactured with screw seat located too high... Class II Preat Corp
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Num... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Mar 24, 2025 Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 8... The associated product labeling does not adequately provide compatibility information for use of ... Class II Zimmer, Inc.
Oct 21, 2024 JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 Firm received complaints reporting that guides were warped when pulled out of packaging. This iss... Class II Biomet, Inc.
May 17, 2024 RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hi... 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to jo... Class II Biomet, Inc.
Mar 22, 2024 Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 22, 2024 Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... Class II EBI, LLC
Mar 13, 2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... Class II Biomet, Inc.
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Nov 2, 2023 Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 One product complaint was received reporting that there was an incorrect adapter in the packaging... Class II Biomet, Inc.
Oct 16, 2023 Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... Class II Zimmer Biomet Spine Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessf... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of u... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccess... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of un... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Oct 9, 2023 Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsucc... Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the d... Class II Biomet, Inc.
Apr 26, 2023 MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Speci... The wrong tibia guide was included intended for a different patient case. Class II Materialise N.V.
Feb 6, 2023 G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Nu... The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 3... Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 29, 2022 (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Kne... Components Incorrectly labeled as either smaller or larger and incorrect side (right/left). Class II Biomet, Inc.
Dec 15, 2022 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to repla... Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than th... Class II Biomet, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Dec 6, 2022 NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Optio... Class II Zimmer, Inc.
Nov 29, 2022 OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For... Product missing the four small locking collar bolts resulting in extension of surgery to find a r... Class II 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.