Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2026 | See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model... | 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:PA... | 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) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 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) DYNDA3003, Model Number: DENTAL PACK; 2) 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) KIT SURG ONC EXCISION BREAST, Model Number:DYKM... | 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) ANGIO PROCEDURE PACK, Model Number:00-401824AB;... | 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 | See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model ... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS,... | 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 Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) C... | 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) 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) ANGIO PROCEDURE PACK, Model Number:00-401824AA;... | 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 Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP24... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GL... | 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) 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) 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) 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) KIT UROLOGY SLING, Model Number: DYKMBNDL106; ... | 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 CATHETER INSERTION TRAY, Model Number: CVI... | 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) CENTRAL LINE UNIVERSAL INSERTI, Model Number: C... | 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) 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) 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) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK... | 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) CVC PACK, Model Number: CVI4500A; 2) TOTE KAM... | 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) 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) 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) 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 | See complete list in RES, exceeds character limit. Medline Surgical Gowns | 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 | See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT ... | Medline has identified issues related to calibration of the equipment used to sterilize and packa... | Class II | Medline Industries, LP |
| Jan 7, 2026 | See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Num... | 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 | Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; | If the connection between a mint Lesion workstation and the mint Lesion server is interrupted whi... | Class II | Mint Medical GmbH |
| Jan 7, 2026 | Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2... | 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 | Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V... | Devices which did not undergo thermoforming could deform and lose performance. | Class II | Olympus Corporation of the Americas |
| Jan 6, 2026 | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
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.