Browse Device Recalls
39,794 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,794 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 39,794 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | 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 7, 2026 | Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containin... | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Class II | INTEGRATED MEDCRAFT LLC |
| Jul 7, 2026 | FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011... | Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Class II | INTEGRATED MEDCRAFT LLC |
| Jul 7, 2026 | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powere... | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss ... | Class II | Olympus Corporation of the Americas |
| Jul 6, 2026 | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, R... | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains ... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Jul 6, 2026 | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride I... | Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance... | Class I | Spectra Medical Devices, Llc |
| Jul 6, 2026 | Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic | Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely d... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 2, 2026 | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17... | Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone gra... | Class II | IsoTis OrthoBiologics, Inc. |
| Jul 1, 2026 | 5-PLASMA Bivalirudin Control, Model Number 5D-44905 | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... | Class II | Aniara Diagnostica LLC |
| Jul 1, 2026 | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... | Class II | Aniara Diagnostica LLC |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product... | Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedulla... | Class II | Biomet, Inc. |
| Jul 1, 2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... | Class II | Aniara Diagnostica LLC |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| Jul 1, 2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Stryker GmbH |
| 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 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... | Class I | Baxter Healthcare Corporation |
| 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 30, 2026 | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Merge OrthoPACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Merge PACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a d... | Class II | Merge Healthcare, Inc. |
| Jun 30, 2026 | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions an... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: ... | Potential for breach in sterile barrier of device packaging. | Class II | Boston Scientific Corporation |
| Jun 30, 2026 | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | The software controlling the wound imaging device's battery charging circuit was not designed to ... | Class II | KENT IMAGING, INC. |
| Jun 30, 2026 | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There ... | Class II | Boston Scientific Corporation |
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.