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 Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations 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 Brand History Cross-category recall lookup by company
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 State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,264 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,264 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 3,264 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 15, 2016 Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209... The device could be subject to breaches of its sterile packaging. Class II Smith & Nephew, Inc.
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 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 13, 2016 MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK... It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK She... Class II Datascope Corporation
Apr 25, 2016 Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-8... Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips w... Class III GSK Consumer Healthcare
Apr 18, 2016 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Prod... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 18, 2016 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product U... The sterile packaging may be compromised. A protective cap is to be secured on the tip of the dr... Class II Synthes (USA) Products LLC
Apr 15, 2016 VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class III Biomerieux France Chemin De L'Or
Apr 14, 2016 Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 14, 2016 Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve ... BBMI recently identified a potential for a tear in the outer blister packaging on a limited numbe... Class II B. Braun Medical, Inc.
Apr 12, 2016 Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabula... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 12, 2016 Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral St... Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supp... Class II Exactech, Inc.
Apr 4, 2016 Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripher... Device packaging may not be sealed. Class II Stryker Sustainability Solutions
Apr 4, 2016 Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175 Device packaging may not be sealed. Class II Stryker Sustainability Solutions
Apr 1, 2016 Various trauma and sports medicine instruments and implants. guide, surgical... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Bit, drill. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Passer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Pin, fixation, ... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Appliance, fixa... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Fastener, fixat... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Plate, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Reamer. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. cannula, surgic... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Orthopedic manu... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Arthroscope. Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Screw, fixation... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... Class II Biomet, Inc.
Apr 1, 2016 Various trauma and sports medicine instruments and implants. Spinal interlam... Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing t... 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.