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
Jan 7, 2026 Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 7, 2026 Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYK... Medline has identified issues related to calibration of the equipment used to sterilize and packa... Class II Medline Industries, LP
Jan 5, 2026 Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... Class II Medline Industries, LP
Jan 5, 2026 Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A... Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... Class II Medline Industries, LP
Jan 5, 2026 Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal S... Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... Class II Medline Industries, LP
Jan 5, 2026 Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM ... Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... Class II Medline Industries, LP
Jan 5, 2026 Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 Medline has identified that the manufacturer of the sterile saline wound wash may not have manufa... Class II Medline Industries, LP
Dec 31, 2025 Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET... Under circumstances involving exposure to particular chemicals and mechanical forces, the male lu... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit S... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG, Ki... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, ... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit i... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY,... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit S... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU D... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 24, 2025 Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit i... Class II Medline Industries, LP
Dec 24, 2025 Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANG... Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing... Class II Medline Industries, LP
Dec 22, 2025 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Liv... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON ... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 E... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 22, 2025 Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... These lots of reprocessed catheters may contain small particles of residual material. If affected... Class I Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTREC... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTIC... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, ... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 16, 2025 Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY ... Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 20... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Ki... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, ... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIA... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Dec 12, 2025 Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA... Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... Class II Medline Industries, LP
Nov 26, 2025 MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... Medline Industries has identified a potential hazard involving the hand control pendant and assoc... Class I Medline Industries, LP

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.