Browse Device Recalls

1,169 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,169 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 1,169 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 7, 2026 Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; ... 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) PLASTIC BIN W/MISC KITS, Model Number: ACC01049... 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) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE14... 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) BURN PACK, Model Number: DYNJ15668R; 2) BURN ... 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) ROBOTIC GYN CDS-1, Model Number: CDS982893I; ... 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) WMC I D PACK-LF, Model Number: DYNJ50806L 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) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; ... 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) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2... 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) PPE KIT, Model Number: DYK1011945P 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) LITHOTOMY PACK, Model Number: DYNJ83185; 2) L... 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) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9... 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 STC TRACHEOSTOMY, Model Number: DYKMBNDL55;... 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 GENERAL CLOSURE, Model Number: DYKMBNDL200A 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) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CD... 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) ADMIT KIT, Model Number: DYKA1343A 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) LVAD DRIVELINE TRAY, Model Number: DM1035; 2)... 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) DRAPE PACK-CHOICE, Model Number: DYNJ63118A 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 ACES INSERT PEG, Model Number: DYKMBNDL130;... 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 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

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.