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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 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 875 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 21, 2019 GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usa... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Pro... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instru... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 ... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 17... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 ... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMR... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
Aug 21, 2019 ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arco... Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning ... Class II Zimmer Biomet, Inc.
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.

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.