Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2024 | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used w... | Screw is 16mm long instead of 22mm long. | Class II | Medartis Inc. |
| Apr 11, 2024 | FDR Visionary Suite - Intended to generate digital or conventional radiograph... | Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, co... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 11, 2024 | Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that ut... | The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting caus... | Class II | Securitas Healthcare LLC |
| Apr 11, 2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... | AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... | Class II | FUJIFILM Healthcare Americas Corporation |
| Apr 10, 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent leve... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Apr 10, 2024 | 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too b... | Due to incorrect milled titanium abutment being packaged and labeled. | Class II | Preat Corp |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Fre... | Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Apr 9, 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... | Class II | Sophysa S.A. |
| Apr 9, 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... | Class II | Sophysa S.A. |
| Apr 9, 2024 | GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON... | Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. | Class II | GE Medical Systems Information Technologies Inc |
| Apr 9, 2024 | Spectrum IQ Infusion pump, Product Code 357009 | There is a potential for cracks on the mount of the front panel of the device. | Class II | Baxter Healthcare Corporation |
| Apr 9, 2024 | VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantita... | T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient ... | Class II | QUIDELORTHO |
| Apr 8, 2024 | see RES for description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number C... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS9... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | See RES Description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1) AN... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pac... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-4016... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | See RES description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-3990... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-40... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC0106... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | See RES description | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Num... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: SHAVE K... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS98... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS9... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) PERIPHERAL ULTRASOUND CATHETER INSE... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UV... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CD... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYN... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pac... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, P... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pa... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CV... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | 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.