Browse Device Recalls

2,910 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,910 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 2,910 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Apr 8, 2024 Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ... 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) GER ARTH BASIN PK RFID-LF , Pack Nu... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYND... 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) C-SECTION TRAY, Pack Number AM160B ... 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) URETEROSCOPY CDS SC-LF, Pack Numbe... 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: KIT,ER SUTURE #1, Pack Number DYNDS1... 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) KIT GENERAL CLOSURE , Pack Number ... 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 procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number... 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 procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584;... 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: PARACERVICAL PUDENDAL BLOCK TR, Pack ... 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) ARTHROGRAPHY DRAPE PACK , Pack Numb... 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) FETOSCOPY CDS-LF, Pack Number CDS8... 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) DIALYSIS CATH ACCESS KIT, Pack Num... 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) LAVH CDS, Pack Number CDS760049AB; ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure packs, containing Caina syringes, labeled as: 1) CIRC... 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 Procedure kits labeled as: 1) CIRCUMCISION SET, Pack Number CIT633... 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 procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYK... 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) PRESSURE TUBING B.I., Pack Number 8... 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) C SCOPE DISPOSABLE KIT, Pack Code ... 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 procedural kits labeled as: 1) LEEP PACK, Pack Number DYNJ40348G; ... 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) PAIN SERVICES CDS , Pack Number CDS... 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: CARDIAC PACING PACK, Pack Number DYNJ... 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 procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number... 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 procedural kits labeled as: 1) BABY ADMIT, Pack Number DYKB1011C; ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 8, 2024 Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MN... 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) COMPREHENSIVE PROCEDURE PACK, Pack ... 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.