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
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... XXX Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 20, 2024 Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test Potential for defective test cartridges which may result in false positive results for the Staphy... Class II Luminex Corporation
Jun 18, 2024 ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377 A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 KIT PEDI CRANI LAMI, Pack Number DYNJ907372A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 18, 2024 CRANIOTOMY PACK, Pack Number DYNJ46552O A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was plac... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 14, 2024 Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 Improperly performed testing prior to release Class II Baxter Healthcare Corporation
Jun 13, 2024 Braun Thermoscan¿ PRO 6000 Ear Thermometer The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) con... Class II Baxter Healthcare Corporation
Jun 4, 2024 VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 40... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 4, 2024 iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 4, 2024 Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical... Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer repo... Class II Baxter Healthcare Corporation
Jun 3, 2024 Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP... During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omit... Class II Baxter Healthcare Corporation
May 30, 2024 Volara System. Blue Ventilator Adapter Module. Intermittent positive pressur... Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... Class I Baxter Healthcare Corporation
May 30, 2024 Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Pa... Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapte... Class I Baxter Healthcare Corporation
May 29, 2024 Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life... Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent c... Class I Baxter Healthcare Corporation
May 29, 2024 Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 29, 2024 Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jian... Class II Cardinal Health 200, LLC
May 9, 2024 Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STC... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syring... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 1... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 9, 2024 Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syrin... Products in distribution were found by FDA to be to be substantially different from the current c... Class II Sol-Millennium Medical Inc.
May 8, 2024 Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare en... There is a potential for the top cover of the hospital bed mattress to delaminate as a result of ... Class II Baxter Healthcare Corporation
May 7, 2024 Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis ... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Plum 360/A+ spare batteries. Item Number: SUB0000864. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & ... Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss... Class I ICU Medical Inc
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Co... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
May 7, 2024 Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Na... Potential for an incomplete seal on the packaging tray. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 30, 2024 MEDLINE STERILE IRIS SCISSORS CVD/STD REF DYNJ04049 (case) and DYNJ04049H (in... There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2024 Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: ... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondVi... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 It has been identified that testing documentation does not support that the syringes can successf... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2024 Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Ar... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-2... Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... Class II Wondfo USA Co Ltd
Apr 22, 2024 MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 It has been identified that testing documentation does not support that the syringes can successf... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 17, 2024 Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881,... These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. L... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 17, 2024 CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... Potential contamination of the product with latex adhesive residual. Class II Cardinal Health 200, LLC
Apr 9, 2024 Spectrum IQ Infusion pump, Product Code 357009 There is a potential for cracks on the mount of the front panel of the device. Class II Baxter Healthcare Corporation
Apr 8, 2024 Medline procedure packs containing Shenli syringes, labeled as follows: NE... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PAC... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield

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.