Browse Device Recalls
40,358 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40,358 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 40,358 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2026 | Halyard IV Start Kit Non-Sterile REF: KRIV26-02 | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which la... | Class II | AVID Medical, Inc. |
| Jul 14, 2026 | Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Num... | Complaints of blue-green discoloration in product | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 14, 2026 | NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Nu... | Complaints of blue-green discoloration in product | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 14, 2026 | GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry... | Complaints of blue-green discoloration in product | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jul 14, 2026 | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# C... | Suture anchor may contain incorrect patient implant card which may result in incorrect device ide... | Class II | ConMed Corporation |
| Jul 14, 2026 | Suture Cinch Long 1pk. Endoscopic tissue approximation device. | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Class II | Boston Scientific Corporation |
| Jul 14, 2026 | Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081... | Hollister has identified that select lots of the catheters identified in the above table may exhi... | Class II | Hollister Ulc |
| Jul 14, 2026 | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Class II | Boston Scientific Corporation |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog N... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 14, 2026 | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Nu... | Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected v... | Class II | Cardinal Health 200, LLC |
| Jul 13, 2026 | Innercool Coolblue Console, Model STx; Thermal regulating system. | Overheating of the 115V CPU board may cause the device to shut down. | Class II | Gentherm Medical, LLC |
| Jul 13, 2026 | Blanketrol III, Model 233; Thermal regulating system. | Overheating of the 115V CPU board may cause the device to shut down. | Class II | Gentherm Medical, LLC |
| Jul 13, 2026 | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jul 13, 2026 | Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 13, 2026 | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jul 13, 2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D... | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient resul... | Class II | Siemens Healthcare Diagnostics Products Ltd. |
| Jul 13, 2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY... | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient resul... | Class II | Siemens Healthcare Diagnostics Products Ltd. |
| Jul 13, 2026 | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jul 13, 2026 | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product ... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 13, 2026 | Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYS... | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the ... | Class II | Kico Knee Innovation Company |
| Jul 13, 2026 | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine As... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 13, 2026 | Blanketrol II Model 222S; Thermal regulating system. | Overheating of the 115V CPU board may cause the device to shut down. | Class II | Gentherm Medical, LLC |
| Jul 13, 2026 | Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x ... | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine As... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 13, 2026 | Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NE... | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wi... | Class II | Medline Industries, LP |
| Jul 13, 2026 | OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Sm... | There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which... | Class II | OBP Medical Corporation |
| Jul 13, 2026 | GM Helix Implant, Endosseous Dental Implant Article No. 109.984 | There may be a mismatch between the implant contained inside the packaging and the information de... | Class II | Straumann USA LLC |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; ... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SK... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU C... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU C... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Cat... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 10, 2026 | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catal... | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated ox... | Class III | Paragon 28, Inc. |
| Jul 10, 2026 | Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU ... | Component labeling discrepancy | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DY... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU C... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visua... | The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation,... | Class II | AVID Medical, Inc. |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline K... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS98... | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Medline Industries, LP |
| Jul 10, 2026 | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitor... | A software vulnerability may allow unauthorized persons to gain privileged access to the device, ... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 9, 2026 | Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 2... | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March... | Class III | Medical Action Industries, Inc. 306 |
| Jul 9, 2026 | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product... | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) ... | Class II | Henry Schein 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.