Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

Clear
DateProductReasonClassFirm
May 20, 2022 EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... Class II DePuy Spine, Inc.
May 20, 2022 EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... Class II DePuy Spine, Inc.
Apr 8, 2019 Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Apr 8, 2019 Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Dec 15, 2017 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Oct 12, 2016 DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. Class II DePuy Spine, Inc.
Nov 20, 2015 Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument ... Manufacturing error within the Torque Handle may prohibit some handles from being able to fully a... Class II DePuy Spine, Inc.
Apr 21, 2015 EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut... Device does not mate as intended. Class II DePuy Spine, Inc.
Jul 31, 2013 PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS D... Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... Class II DePuy Spine, Inc.
Jul 31, 2013 PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS D... Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... Class II DePuy Spine, Inc.
Jul 31, 2013 PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dila... Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... Class II DePuy Spine, Inc.
Jul 31, 2013 PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holdi... Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... Class II DePuy Spine, Inc.
Jul 31, 2013 PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Di... Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which i... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diame... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Nov 7, 2012 DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 ... Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diam... Class II DePuy Spine, Inc.
Jul 24, 2012 DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potent... Class II DePuy Spine, 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.