Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 14, 2024 | Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD722... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Lo... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 14, 2024 | BD Pyxis CII Safe ES, REF: 1116-00 | Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or ... | Class II | CareFusion 303, Inc. |
| Nov 14, 2024 | Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. ... | Potential for the outer stainless-steel tube to break or detach. | Class I | Kirwan Surgical Products, LLC |
| Nov 13, 2024 | Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Cat... | Increase in complaints associated with a molding defect within the inner lumen of delivery cartri... | Class II | Alcon Research LLC |
| Nov 13, 2024 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137 | The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler p... | Class II | Beckman Coulter, Inc. |
| Nov 12, 2024 | ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | RUMMELL, Medline Item No. ST006ST | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870 | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 12, 2024 | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 ... | Some units in a single production lot were programmed incorrectly which will result in the VivAer... | Class II | Aerin Medical, Inc. |
| Nov 12, 2024 | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens M... | Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (M... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 12, 2024 | ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 11, 2024 | TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) | An out of specification component may result in the device exhibiting torque output higher than t... | Class II | Gauthier Biomedical, Inc. |
| Nov 11, 2024 | Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. All... | Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCT... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Numbe... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog ... | The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the ... | Class II | Beckman Coulter Inc. |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Pro... | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... | Class II | O&M HALYARD, INC. |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical... | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Fac... | Class II | O&M HALYARD, INC. |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. | Class II | Hologic, Inc. |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | Class II | Cardinal Health 200, LLC |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Class II | Cardinal Health 200, LLC |
| Nov 7, 2024 | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the pr... | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasor... | Class II | Diasorin Inc. |
| Nov 6, 2024 | BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicil... | BD identified through potency testing as part of a stability test request to monitor Ampicillin A... | Class II | Becton Dickinson & Co. |
| Nov 6, 2024 | Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANI... | Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.