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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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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

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Browse Device Recalls

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SURG GOWN L 2 TOWELS, Item Code ASG9511 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 3XL, Item Code 9585 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 GOWN SURG LG W/TOWEL ST BACK, Item Code 9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK XLARGE, Gown. Item Code 9548 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK LARGE, Gown. Item Code 9518 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURGICAL GOWN XL, Item Code 9545 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREINF SURGICAL GOWN 4XL, Item Code 9599 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541 The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 11, 2020 AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown parti... Class II Cardinal Health
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Jan 2, 2020 Central Venous Catheters are indicated for the assessment of hemodynamic stat... Inability for the guidewire to pass through the needles included with the catheter kits. Class II ICU Medical, Inc.
Dec 19, 2019 LEGION PS High Flex XLPE size 5-6 9mm Articular Insert LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part Class II Smith & Nephew, Inc.
Dec 11, 2019 Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion Circumsion Trays as follows: Kit Code Product ... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- LC145 STERILE NICU LINE CHANGE KIT Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 11, 2019 Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10... Incomplete seals on the sterile package may compromise the sterility Class II Centurion Medical Products Corporation
Dec 3, 2019 Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, ... Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased pos... Class II Johnson & Johnson Surgical Vision Inc
Dec 2, 2019 HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob... Class II Thoratec Corp.
Nov 27, 2019 QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI:... If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during e... Class II Edwards Lifesciences, LLC
Nov 21, 2019 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... Pin To Rod Coupling could not clamp the pin and rod as intended Class II Stryker GmbH
Nov 15, 2019 O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ... Class II Medtronic Navigation, Inc.-Littleton
Nov 15, 2019 Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L There is the potential presence of particular matter in the header caps of ten lots the Revaclear... Class II Baxter Healthcare Corporation
Oct 10, 2019 Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular locking plate elbow-sterile, Item Nos. 47235800503 4723580050... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 ... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 0023470030... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect s... Class II Nextremity Solutions
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical
Oct 8, 2019 Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, P... The safety cap attached to needles within the needle sets may become dislodged exposing the needl... Class II Teleflex Medical

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.