Browse Device Recalls

1,300 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,300 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 1,300 FDA device recalls.

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DateProductReasonClassFirm
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored... Unapproved design changes to the products outside of the 510(k) clearance. Class II Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 27, 2026 Medline medical convenience kits, containing NAMIC Angiographic Rotating Adap... Medline Industries, LP has identified through post-market surveillance a potential risk of the sy... Class I Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO AN... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYR... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TR... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440 The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJS... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number:... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; ... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PAC... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO P... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model N... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DY... The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 25, 2026 Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure T... Class II Medline Industries, LP
Feb 18, 2026 Sterile Radiology Procedure Kits, Model Number DYNDH1491B There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which m... Class II Medline Industries, LP
Feb 16, 2026 MEDLINE ANTERIOR HIP PACK DYNJ64672B Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP
Feb 16, 2026 Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2... Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints a... Class II Medline Industries, LP

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.