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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
May 22, 2018 Tri-Staple 2.0 Black Intelligent Reload for use with Signia stapling system 6... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat.... The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... Class II Randox Laboratories Ltd.
May 22, 2018 Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat.... The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... Class II Randox Laboratories Ltd.
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 18... Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound ... Class II NewDeal SA
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111... Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound ... Class II NewDeal SA
May 22, 2018 Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technolo... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tec... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, It... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm ... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Tech... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S,... Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound ... Class II NewDeal SA
May 22, 2018 UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 3... Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound ... Class II NewDeal SA
May 22, 2018 TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 15011... Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound ... Class II NewDeal SA
May 22, 2018 Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat.... The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... Class II Randox Laboratories Ltd.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, 6260-9-036 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling sys... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, I... Device may be missing a sled component. The sled component is responsible for staple deployment. ... Class II COVIDIEN MEDTRONIC
May 21, 2018 Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01... The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw ... Class II Philips Medical Systems (Cleveland) Inc
May 18, 2018 OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... The Internal packaging, the pouch and patient labels are improperly labeled. Class II OMNIlife science Inc.
May 18, 2018 Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY2... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, CO... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (s... One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may le... Class II Zimmer Biomet, Inc.
May 18, 2018 TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDM... GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the po... Class II Guangzhou Wondfo Biotech Co., Ltd.
May 18, 2018 AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and... Potential for control line not appearing on the test strip Class I Qiagen Sciences, Inc.
May 18, 2018 REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 Due to out of specification, the clinician would not be able to fit and engage the abutment with ... Class II Implant Direct Sybron Manufacturing, LLC
May 18, 2018 EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ... There is a potential for a disruption in one or more of the triple layer membranes of the ventric... Class I BERLIN HEART GMBH
May 17, 2018 VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Produc... Product pouch label may not easily identify the lot number, expiration date and associated symbo... Class II Arrow International Inc
May 17, 2018 VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide... Product pouch label may not easily identify the lot number, expiration date and associated symbo... Class II Arrow International Inc
May 17, 2018 The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Contro... An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibr... Class II Intuitive Surgical, Inc.
May 17, 2018 VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To prov... Product pouch label may not easily identify the lot number, expiration date and associated symbo... Class II Arrow International Inc
May 17, 2018 Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-... Product pouch label may not easily identify the lot number, expiration date and associated symbo... Class II Arrow International Inc
May 16, 2018 The,K -ASSAY HP assay is intended for the quantitative determination of hum... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of t... Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved ... Class II Elekta, Inc.
May 16, 2018 C3 is an in vitro diagnostic assay for the quantitative determination of C3 i... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 Transferrin is an in vitro diagnostic assay for the quantitative determinatio... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, 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.