Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2026 | Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 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) OR ARTERIOGRAM, Model Number: CDS985094F; 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) OPEN HEART CDS, Model Number: CDS840015AQ; 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) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: P... | 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) ARTHROSCOPY CDS, Model Number: CDS984609B; 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) HYSTEROSCOPY, Model Number: CDS984086I; 2) KI... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 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) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U;... | 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 OPHTHALMIC RUPTURE GLOBE, Model Number: DYK... | 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) DENTAL PACK, Model Number: DYNDA3003 | 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) PICC LINE TRAY, Model Number: 00-401993O; 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 Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJ... | 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) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYK... | 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) OB KIT, Model Number: DYKM2326; 2) KIT LABOR ... | 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) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 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) 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 |
| Jan 2, 2026 | Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. | Tyvek bag seal issue which may compromise sterility of the kit. | Class II | AVID Medical, Inc. |
| Dec 15, 2025 | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ... | Access Port System tray may develop cracks potentially resulting in a sterility breach. | Class II | Intuitive Surgical, Inc. |
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research LLC |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 3, 2025 | SQ40S Blood Transfusion Filter | Due to products being released for distribution prior to completion of the required quality contr... | Class II | GVS TM, Inc |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | 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.