Browse Device Recalls
1,522 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,522 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 1,522 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| Jun 10, 2026 | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE... | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformi... | Class II | Medline Industries, LP |
| 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. |
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.