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 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 14, 2022 Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 Cardinal Health recently received multiple complaints regarding various performance issues with C... Class II Cardinal Health 200, LLC
Dec 9, 2022 Alinity m System. The Alinity m System is designed to automate the steps... The firm identified the following three potential issues which may have impacted ADUs installed o... Class II Abbott Molecular, Inc.
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Re... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY,... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 23, 2022 Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class II Baxter Healthcare Corporation
Nov 23, 2022 Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and a... Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer Class II Baxter Healthcare Corporation
Nov 23, 2022 Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA... Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer Class II Baxter Healthcare Corporation
Nov 23, 2022 Revaclear 400 dialyzers. Indicated for treatment of chronic and acute re... Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class II Baxter Healthcare Corporation
Nov 23, 2022 Revaclear 300 dialyzers. Indicated for treatment of chronic and acute re... Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak Class II Baxter Healthcare Corporation
Nov 22, 2022 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Reports of an increase in reactive negative controls and false positive results with certain lots... Class II Abbott Molecular, Inc.
Nov 22, 2022 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 Reports of an increase in reactive negative controls and false positive results with certain lots... Class II Abbott Molecular, Inc.
Nov 21, 2022 Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... Class II Leica Microsystems, Inc.
Nov 21, 2022 Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standa... There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... Class II Leica Microsystems, Inc.
Nov 21, 2022 Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... Class II Leica Microsystems, Inc.
Nov 18, 2022 Medline CISION Sterile Blades. Labeled as follows with corresponding Item Nu... Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. 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.