Browse Device Recalls
2,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,087 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 2,087 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 11, 2026 | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 006901032109... | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetr... | Class II | Becton, Dickinson and Company |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex ... | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during... | Class I | CooperSurgical, Inc. |
| Aug 11, 2026 | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-... | Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during... | Class I | CooperSurgical, Inc. |
| Aug 11, 2026 | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DY... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) AC... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; ... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYND... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number:... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM... | The kits contain certain lots of sterile applicators which may contain fungal contamination that ... | Class I | Medline Industries, LP |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2026 | PLASTICS TRAY; Model/Item Number (Kit): EURO053; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | HEART PREP TRAY; Model/Item Number (Kit): MECV97W; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | MAJOR PACK; Model/Item Number (Kit): NIHB0018-11; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH1... | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064... | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11; | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Class II | AVID Medical, Inc. |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, ... | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and... | Class II | Merit Medical Systems, Inc. |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784;... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. ... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; ... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Numbe... | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the ... | Class II | Cardinal Health 200, LLC |
| Aug 10, 2026 | Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197... | The kits contain neurological sponges with the potential for unexpected variability of endotoxin ... | Class II | Medline Industries, LP |
| Aug 10, 2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SI... | Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due t... | Class II | Medline Industries, LP |
| Aug 10, 2026 | DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short... | this is a downstream recall of class I recall RES 98777 | Class I | Bard Access Systems, Inc. |
| Aug 10, 2026 | Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-... | this is a downstream recall of class I recall RES 98777 | Class I | Bard Access Systems, Inc. |
| Aug 10, 2026 | Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02; | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampu... | Class I | AVID Medical, Inc. |
| Aug 10, 2026 | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-51... | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Aug 10, 2026 | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 | Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... | Class II | Fresenius Medical Care Renal Therapies Group, 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.