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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 16, 2018 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device ... Correction vector confirmation message is lost if access point is changed after sending the corr... Class II Ion Beam Applications S.A.
May 16, 2018 BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers... Class III Becton, Dickinson and Company, BD Biosciences
May 16, 2018 DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model... Possible nonconforming blades may result in a higher than specified cut force required to cut the... Class II Ceterix Orthopedics, Inc.
May 16, 2018 Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glu... CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and di... Class II Medtronic Inc.
May 16, 2018 RECON DRILL 6MM X 439MM; 14-443023 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 BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 C4 is an in vitro diagnostic assay for the quantitative determination of C4 i... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 ... The firm is recalling various trauma guide wires due to insufficient packaging design verificatio... Class II Zimmer Biomet, Inc.
May 16, 2018 G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 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 15, 2018 MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 If two devices are plugged into the same channel/port in the generator, both devices activate. If... Class II Megadyne Medical Products, Inc.
May 15, 2018 CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: ... Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered hig... Class II CAREstream Medical LLC
May 15, 2018 Draeger Jaundice Meter JM-105 The device is intended for use in hospitals,... Users have misinterpreted the display for out of range measurement indicated by the blinking "-... Class I Draeger Medical Systems, Inc.
May 15, 2018 XLTEK EMU40EX EEG Headbox Possible degradation of an internal electronic component over time which may cause the XLTEK EMU ... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 15, 2018 Draeger Jaundice Meter JM-103 The device is intended for use in hospitals... Users have misinterpreted the display for out of range measurement indicated by the blinking" ... Class I Draeger Medical Systems, Inc.
May 14, 2018 Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020 Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico... Class II CryoLife, Inc.
May 14, 2018 Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model... In vitro diagnostic devices, used greater than 6 months after date of manufacture, may have incre... Class II Merck Millipore Ltd.
May 14, 2018 Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxico... Class II CryoLife, Inc.
May 14, 2018 O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model... Higher levels of nitrous oxide delivered than specification Class II O-Two Medical Technologies, Inc.
May 14, 2018 Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, ... Possible diminished performance prior to its established expiration date. Class II Opgen Inc
May 14, 2018 Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co... After receipt of a product complaint for the labeling, it was determined that this device does no... Class II Encore Medical, Lp
May 14, 2018 Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to m... Blades are loose in handles and may fall out due to non cured epoxy Class II Beaver Visitec
May 11, 2018 Olympus JF-160F duodenoscopes (Model NumberJF-160F) Issuance of validated, new reprocessing procedures. The new cleaning procedure requires additiona... Class II Olympus Corporation of the Americas
May 11, 2018 Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for u... The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 si... Class II Zimmer Biomet, Inc.
May 11, 2018 Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR C... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) S... The affected devices are manufactured to the same design specification as products intended for s... Class II Smith & Nephew, Inc.
May 11, 2018 Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS... The recalling firm has received complaints related to increased resistance encountered when intro... Class II Arrow International Inc
May 11, 2018 Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle El... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 11, 2018 Olympus JF-140F duodenoscopes (Model NumberJF-140F) Issuance of validated, new reprocessing procedures. This corrective action is being undertaken ... Class II Olympus Corporation of the Americas
May 11, 2018 Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF... The affected devices are manufactured to the same design specification as products intended for s... Class II Smith & Nephew, Inc.
May 11, 2018 Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shroude... Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being c... Class II Olsen Medical
May 10, 2018 Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical Inc.)
May 10, 2018 RS 5F DL BIOFLO PASV, Catalog Number 60M161567 A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). Class II Angiodynamics Inc. (Navilyst Medical 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.