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 |
|---|---|---|---|---|
| Feb 27, 2026 | Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (C... | Class II | Spacelabs Healthcare, Inc. |
| 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 27, 2026 | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1... | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Sy... | Class II | Cardinal Health 200, LLC |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTI... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: S... | Following a complaint investigation, Olympus identified a potential defect in the 24V power suppl... | Class II | Olympus Corporation of the Americas |
| Feb 27, 2026 | SIGNA Premier systems | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of... | Class II | GE Healthcare LLC |
| 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 25, 2026 | 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... | Class II | Synthes (USA) Products LLC |
| Feb 25, 2026 | 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.4... | Class II | Synthes (USA) Products LLC |
| Feb 25, 2026 | Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PK... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
| Feb 25, 2026 | Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting ... | Olympus identified that the Cutting Forceps contain components for which the supplier did not ade... | Class II | Olympus Corporation of the Americas |
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.