Browse Device Recalls
2,908 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,908 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 2,908 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 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 |
| 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 | 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 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 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 26, 2025 | Chest Drainage Units and Accessories: Product Code Description 1. 88885... | The firm is updating the IFU to clarify the intended patient population for the identified chest ... | Class II | Cardinal Health 200, LLC |
| 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 22, 2025 | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medi... | BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packagi... | Class II | LSL Healthcare Inc. |
| 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 15, 2025 | Plum Duo Infusion System, List Number 40002-04-01 | ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl... | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a... | Class II | Sysmex America, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
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.