Browse Device Recalls
5,540 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,540 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 5,540 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 18, 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Olympus Corporation of the Americas |
| Jul 16, 2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxoli... | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently con... | Class II | Straumann USA LLC |
| 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 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 | 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 | 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 | 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 | 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 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY ... | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 9, 2026 | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03 | Labeling Deficiency: The medical kit labeling fails to identify that the statlock component conta... | Class II | AVID Medical, Inc. |
| Jul 8, 2026 | Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline... | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... | Class II | Medline Industries, LP |
| Jul 8, 2026 | Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline ... | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... | Class II | Medline Industries, LP |
| Jul 8, 2026 | Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SK... | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... | Class II | Medline Industries, LP |
| Jul 8, 2026 | Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Ki... | Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges ... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 17, 2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... | Class II | Freudenberg Medical, LLC |
| Jun 17, 2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... | Class II | Freudenberg Medical, LLC |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pac... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr F... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KI... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tra... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cat... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerv... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog N... | Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be... | Class II | TISSIUM SA |
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.