Browse Device Recalls

35,653 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,653 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 35,653 FDA device recalls, Class II.

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DateProductReasonClassFirm
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 15, 2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... Class II Abbott Medical
Feb 14, 2025 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12... A problem was discovered during the scanning process of the outer carton label because of an inco... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 14, 2025 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 1... A problem was discovered during the scanning process of the outer carton label because of an inco... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 14, 2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100 Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... Class II Smiths Medical ASD, Inc.
Feb 14, 2025 Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13... A problem was discovered during the scanning process of the outer carton label because of an inco... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 14, 2025 CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214 Airway adapter does not meet specification and may break off when attaching a valve or tube. Devi... Class II Smiths Medical ASD, Inc.
Feb 13, 2025 Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY ... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro dia... Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... Class II Remel, Inc
Feb 13, 2025 Proxima Drape labeled as FACE LIFT. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnosti... Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... Class II Remel, Inc
Feb 13, 2025 Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC... Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape. Potential breach in pouch packaging which could lead to loss of sterility. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical con... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 8064172... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG;... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 Z1 Femoral Hip System, Product Number 611777612 There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the d... Class II Zimmer, Inc.
Feb 12, 2025 Mito Red Light, Super Mobile The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it ... Class II MITO RED LIGHT INC
Feb 12, 2025 namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, R... The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 12, 2025 Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may hav... Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fir... Class II Remel, Inc
Feb 12, 2025 BD BBL TB Stain Kit K, Catalog (REF): 212522 One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate o... Class II Becton Dickinson & Co.
Feb 11, 2025 Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ09230... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Numbe... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJ... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ800... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... The incorrect computed patient age is showing in VX for patients less than 3 months old. Class II FUJIFILM Healthcare Americas Corporation
Feb 11, 2025 Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number D... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Nu... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 11, 2025 Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 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.