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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,029 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,029 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 3,029 FDA device recalls in 2016.

Clear
DateProductReasonClassFirm
May 27, 2016 Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 ROSA Brain 3.0 Intended for the spatial positioning and orientation of instr... Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. Class II Zimmer Biomet, Inc.
May 27, 2016 Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring de... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For color... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For colori... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For colo... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For colorin... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring d... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For c... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 27, 2016 Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring ... The primary packaging of these products may show leaks in individual cases. As a consequence, the... Class II Ivoclar Vivadent, Inc.
May 26, 2016 ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 108197... Eight (8) issues were identified which may affect the results generated by the system software ve... Class II Siemens Healthcare Diagnostics, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 714... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 714... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Van... Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin as... Class II Roche Diagnostics Operations, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 7142... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 7142... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 714213... The surface inside of the femoral component, where cement is applied for adhesion, is below speci... Class II Smith & Nephew, Inc.
May 26, 2016 Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femor... Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the... Class II Exactech, Inc.
May 26, 2016 Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink ... Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Mon... Class II Medtronic Inc., Cardiac Rhythm and Heart Failure
May 25, 2016 BrightView X, model #882478; gamma camera designed for single or dual detecto... The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... Class II Philips Medical Systems (Cleveland) Inc
May 25, 2016 LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s... LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initia... Class II Physio-Control, Inc.
May 25, 2016 BrightView XCT Upgrade Model 882454 The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... Class II Philips Medical Systems (Cleveland) Inc
May 25, 2016 BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed... The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, re... Class II Philips Medical Systems (Cleveland) Inc
May 25, 2016 iConnect Access software. The firm name on the label is Merge Healthcare, Ha... Software displayed incorrect prior reports in the viewport area, only when more than one prior st... Class II Merge Healthcare, Inc.
May 24, 2016 CENTURION Vision System The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment ... Class II Alcon Research, Ltd.
May 24, 2016 TriFoillmaging Triumph/Triumph II Research CT scanners. The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northrid... Class II Northridge Tri-Modality Imaging,
May 24, 2016 Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-... Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine... Class II Fresenius Medical Care Renal Therapies Group, LLC
May 24, 2016 VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ... Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI... Class III Ortho-Clinical Diagnostics
May 24, 2016 QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systemat... Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improp... Class II Hardy Diagnostics
May 23, 2016 TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 T... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 DeVilbiss Model 7305P-D Powered Suction Unit A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature fai... Class II DeVilbiss Healthcare LLC
May 23, 2016 PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Presence of leaks near top of the PrismaSate bags Class II Baxter Healthcare Corp.
May 23, 2016 TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 ... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 OT1000 Series Orthopedic Surgical Tables STERIS has identified that the pivot pin assembly located on the table top may become loose preve... Class II Steris Corporation
May 23, 2016 TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Ti... DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titani... Class II Synthes (USA) Products LLC
May 23, 2016 EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethyl... Medtronic is issuing a medical device recall to return product potentially associated with an out... Class II Ev3, 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.