Browse Device Recalls

3,306 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,306 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 3,306 FDA device recalls in IL.

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DateProductReasonClassFirm
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
Nov 18, 2022 Cardinal Health Presource Packs IV START KIT- Intended for IV access device ... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 18, 2022 Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 18, 2022 Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... Class II Cardinal Health 200, LLC
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTIO... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. S... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: IM NAIL Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR B... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b.... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 ANCILLARY PACK-LF. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CD... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 TRACH PACK. Sterile Procedural Tray. Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: LS MS PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as CRANI, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HA... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-L... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. L... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-L... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... 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.