Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| 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 |
| Aug 6, 2026 | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Number... | The linear actuator and rotational lock mechanism components may experience a mechanical failure ... | Class II | IMRIS Imaging Inc |
| Aug 6, 2026 | ORT200, operating room table, including the ORT200 Covered Table Assembly, Re... | The linear actuator and rotational lock mechanism components may experience a mechanical failure ... | Class II | IMRIS Imaging Inc |
| Aug 4, 2026 | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digit... | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X... | Class II | Canon Medical System, USA, INC. |
| Jul 29, 2026 | healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative... | Test manufactured with an expired ingredient which may present as either a false negative or posi... | Class II | Healthmark Industries Co., Inc. |
| Jul 29, 2026 | healthmark ProChek-II, Model Number PT-313, PT-201-12 | Test manufactured with an expired ingredient which may present as either a false negative or posi... | Class II | Healthmark Industries Co., Inc. |
| Jul 24, 2026 | Ami HTX | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. | Class II | Spectral Instruments Inc |
| Jul 24, 2026 | Lago X | Momentary absence of On-Screen "X-Ray On" banner during run readiness check. | Class II | Spectral Instruments Inc |
| Jul 22, 2026 | FUJIFILM Synapse PACS software v7.4.310; radiological image processing system | Software issue may cause the ruler measurement to be inaccurate. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jul 22, 2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Merge Healthcare, Inc. |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Dentsply Sirona Capsule Mixer Model No. 5546068 | Potential for electrical discharge from unit when unplugged. | Class II | SDI Limited |
| Jul 20, 2026 | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Soft... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 570... | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software ... | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... | Class II | Midmark Corporation |
| Jul 20, 2026 | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addit... | Class II | GE Medical Systems Information Technologies Inc |
| Jul 20, 2026 | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#... | Due to a firmware defect, the portable organ transfer device datalogger may lose its configuratio... | Class II | Paragonix Technologies Inc. |
| Jul 17, 2026 | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number ... | Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria... | Class II | Remel Europe Ltd. |
| Jul 16, 2026 | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 7220... | Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degr... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 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 16, 2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 7222... | Two software related issues: 1) Potential image quality degradation that may lead to delay of t... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jul 16, 2026 | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)008514580051... | Firm has identified mismatches between the outbreak strain and the reference strain used in the d... | Class II | Biofire Defense |
| Jul 15, 2026 | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5... | a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... | Class II | Beckman Coulter Inc. |
| Jul 15, 2026 | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1... | a software defect in which the Parameter Package (PP) import logic overwrites all predefined cal... | Class II | Beckman Coulter Inc. |
| 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. |
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.