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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

3,087 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,087 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 3,087 FDA device recalls in IL.

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DateProductReasonClassFirm
Dec 18, 2018 Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical i... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical inst... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instr... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 18, 2018 Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product ... Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal... Class II Angiotech (Manan Medical Products, Inc.)
Dec 11, 2018 AMIA Automated Peritoneal Dialysis System Product Usage: It is intended ... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 11, 2018 Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended... Potential for the software on Automated PD System cyclers which can cause shortened dwell times d... Class II Baxter Healthcare Corporation
Dec 5, 2018 Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100 The sterility may be compromised due to a potential breach in the packaging, even though it may a... Class III Medela Inc
Dec 5, 2018 Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, include... A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged S... Class II Sage Products Inc
Nov 30, 2018 Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biogr... Improper design or specifications. Class II Siemens Medical Solutions USA, Inc.
Nov 8, 2018 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 I... There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow... Class II ICU Medical Inc
Nov 2, 2018 GEM Coupler Forceps, GEM4183C, packaged individually. Potential presence of rust on Coupler Forceps (GEM4183C). Class II Baxter Healthcare Corporation
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile ligh... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glov... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 31, 2018 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light ... Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carm... Class II Cardinal Health 200, LLC
Oct 10, 2018 L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... Class II Baxter Healthcare Corporation
Oct 5, 2018 EVO Excel, Emission Computed Tomographic System, Material Number 10910501 The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l... Class II Siemens Medical Solutions USA, Inc.
Sep 28, 2018 Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105... The terminals on the plug may become loose and overheat. Class II Siemens Medical Solutions USA, Inc.
Sep 28, 2018 Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material... The terminals on the plug may become loose and overheat. Class II Siemens Medical Solutions USA, Inc.
Sep 17, 2018 BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with... The power supply unit for the printer used with the device can potentially overheat or cause a fi... Class II Leica Microsystems, Inc.
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used t... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 12, 2018 EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to ... Potential ability to leak once used for compounding. Class II Baxter Healthcare Corporation
Sep 4, 2018 Leica M525 F20 Surgical Microscope System The firm received complaints that the instrument tipped over when the swing arm was fully extended. Class II Leica Microsystems, Inc.
Sep 4, 2018 Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological ... Product was assembled with an isolating fiberglass hose within the oven in the wrong position. Th... Class II Leica Microsystems, Inc.
Aug 30, 2018 Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers... Firm received sporadic reports of discoloration on certain lots of the product, which has been id... Class II MEDLINE INDUSTRIES INC
Aug 14, 2018 Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC... The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact wit... Class II Ohio Medical Corporation
Aug 1, 2018 Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model ... A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a ... Class II ICU Medical Inc
Jul 27, 2018 Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.... The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsel... Class II Sysmex America, Inc.
Jul 12, 2018 power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguy... There were instances where the power cord socket detached from the back of the AMIA cycler when t... Class II Baxter Healthcare Corporation
Jun 25, 2018 Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. Recall is due to a design weakness of the power insert module. Class II Leica Microsystems, Inc.
Jun 20, 2018 The Tri-Flo Subglottic Suction System Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Sub... Class I Vyaire Medical
Jun 15, 2018 Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... Class II Medline Industries Inc
Jun 13, 2018 Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Us... These devices have an incorrect specification against safety standard ISO61010-1. Should a single... Class II Leica Microsystems, Inc.
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double S... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, ... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref A... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC
Jun 11, 2018 Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette... The suction valve may not close properly which could cause continuous suction. Class II Cardinal Health 200, LLC

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.