Browse Device Recalls
1,130 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,130 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 1,130 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2019 | Comprehensive RS Cleat CAP, Item No. 110300 | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin ... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product U... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM000009... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 21, 2019 | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331... | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 91mm Item # 195761 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 83 mm Item # 195253 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 69mm Item # 195272 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 67mm Item # 195271 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 87 mm Item # 195760 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 87 mm Item # 195254 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP- CR Tibial Tray- Interlok 59mm Item # 195268 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 71 mm Item # 195755 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 71 mm Item # 195249 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 63 mm Item # 195751 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 79 mm Item # 195276 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 73mm Item # 195274 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 65mm Item # 195270 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 71mm Item # 195273 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 75 mm Item # 195757 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 69 mm Item # 195248 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 67 mm Item # 195753 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 63mm Item # 195269 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 65 mm Item # 195246 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 69 mm Item # 195754 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 83 mm Item # 195277 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 67 mm Item # 195247 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 79 mm Item # 195252 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 91 mm Item # 195279 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 73 mm Item # 195756 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 83 mm Item # 195759 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 73 mm Item # 195250 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 87 mm Item # 195278 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Interlok 75mm Item # 195275 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 63 mm Item # 195245 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 59 mm Item # 195750 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | Vanguard XP Tibial Tray 75 mm Item # 195251 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 65 mm Item # 195752 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 15, 2019 | XP-XP Tibial Tray - Interlok 79 mm Item # 195758 | The locking bar not fully engaging | Class II | Zimmer Biomet, Inc. |
| Aug 6, 2019 | ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331 | The potential that the end of the shaft could fail to effectively mate with the broach with the C... | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jul 2, 2019 | Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812 | Cleaning processes potentially being ineffective | Class II | Zimmer Biomet, Inc. |
| Jun 10, 2019 | Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only)... | Lack of an adequate sterilization validation. | Class II | Zimmer Biomet, Inc. |
| Jun 10, 2019 | Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only)... | Lack of an adequate sterilization validation. | Class II | Zimmer Biomet, Inc. |
| Jun 4, 2019 | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Ite... | The products do not have sufficient data to support the labeled shelf life of 10 years. | 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.