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

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The produ... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 b... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 box... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 bo... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluid... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 23, 2017 Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The prod... Insufficient documentation to support product sterility claims. Class II International Medsurg Connection, Inc.
Jun 15, 2017 Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... Class II DeRoyal Industries Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp

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.