Browse Device Recalls

1,001 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,001 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 1,001 FDA device recalls.

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DateProductReasonClassFirm
Oct 1, 2025 Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Gener... Medline Renewal has determined that certain areas on the device have the potential to trap residu... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 30, 2025 MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class II Medline Industries, LP
Sep 11, 2025 Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Num... Medline has identified a limited quantity of saline IV flush syringes that may not meet the requi... Class II Medline Industries, LP
Sep 10, 2025 Medline Adult Anesthesia Set, REF DYNJ39985G Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due t... Class II Medline Industries, LP
Aug 21, 2025 Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-... The kits contain certain lots of cannula products where the catheter may not retain its shape. Class I Medline Industries, LP
Aug 8, 2025 Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Aug 8, 2025 Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Jul 31, 2025 Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 25, 2025 Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 25, 2025 Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 23, 2025 Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 14, 2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 8, 2025 The Medline General Surgery Tray is customized to meet requirements of the ho... Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 16, 2025 SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE01... SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due t... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 23, 2025 Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... Class II MEDLINE INDUSTRIES, LP - Northfield
May 15, 2025 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile pr... Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACC... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SK... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 22, 2025 Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A... Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequa... Class I MEDLINE INDUSTRIES, LP - Northfield
Apr 9, 2025 Centurion Sterile Weitlaner Retractor, Reorder: 67315 Three is the potential for the retractors to puncture through the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 9, 2025 Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395 Three is the potential for the retractors to puncture through 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.