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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
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.
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 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 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.
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.
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.
Feb 14, 2022 BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pl... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM ... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Siz... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jan 7, 2022 Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Pla... The products in scope underwent an incorrect rework operation for the porous plasma sprayed coati... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM I... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... Class II Biomet, Inc.
Jun 2, 2021 Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM ... Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosio... 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.