PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Recalls in Medical Devices

Newest first · Page 114 of 808

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Ophthalmic…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Ophthalmic…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Microtek Medical Inc.

FDA Devices Moderate Aug 28, 2024

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

Ventana Medical Systems, Inc.

FDA Devices Moderate Aug 28, 2024

Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 28, 2024

Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assemblage o…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

GM60A. Digital Diagnostic Mobile X-Ray System.

NeuroLogica Corporation

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Op…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 28, 2024

Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophthalmic kn…

Alcon Research LLC

FDA Devices Moderate Aug 28, 2024

C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Microtek Medical Inc.

FDA Devices Moderate Aug 28, 2024

Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).

Microtek Medical Inc.

FDA Devices Moderate Aug 28, 2024

Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, RE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Aug 28, 2024

Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A;…

MEDLINE INDUSTRIES, LP - Northfield

CPSC Moderate Aug 22, 2024

Head Rush Technologies Recalls TRUBLUE Speed Auto Belay Devices Due to Fall Hazard

Head Rush Technologies, of Louisville, Colorado

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management …

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Cathete…

Merit Medical Systems, Inc.

FDA Devices Low Aug 21, 2024

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro d…

DRG International, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit)…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tray - Fl…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold Kit), …

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Cepheid, Sample Collection Device, Part: 900-0370

Cepheid

FDA Devices Moderate Aug 21, 2024

Discrete photometric chemistry analyzer for clinical use.

Beckman Coulter, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF:K0…

Merit Medical Systems, Inc.

FDA Devices Critical Aug 21, 2024

Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618…

ICU Medical Inc

FDA Devices Moderate Aug 21, 2024

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

Boston Scientific Neuromodulation Corporation

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring …

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection image…

Palodex Group Oy

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Procedure Tr…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiogra…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit), REF: …

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Compo…

EYE COMFORT CARE LLC

FDA Devices Critical Aug 21, 2024

RMU-2000 Automated Chest Compression Device

Defibtech, LLC

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suctio…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Ortho-Clinical Diagnostics, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monit…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure vi…

DKK Dai-Ichi Shomei Co., Ltd.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiograph…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Managem…

Merit Medical Systems, Inc.

FDA Devices Moderate Aug 21, 2024

HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately…

Thoratec LLC

FDA Devices Moderate Aug 21, 2024

L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

Argon Medical Devices, Inc

FDA Devices Critical Aug 21, 2024

Plum 360/A+ spare batteries. Item Number: SUB0000864.

ICU Medical Inc

FDA Devices Moderate Aug 21, 2024

Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure v…

DKK Dai-Ichi Shomei Co., Ltd.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management …

Merit Medical Systems, Inc.

FDA Devices Critical Aug 21, 2024

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS uni…

ICU Medical Inc

FDA Devices Moderate Aug 21, 2024

Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure v…

DKK Dai-Ichi Shomei Co., Ltd.

FDA Devices Moderate Aug 21, 2024

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

FDA Devices Moderate Aug 21, 2024

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Cat…

Merit Medical Systems, Inc.

What to do with this

Monitoring medical devices? Start here.

  • Check a specific product against the full federal archive before you use or buy it. Recall checker
  • Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
  • Sort the whole archive by severity to see the highest-risk active recalls first. Rankings

Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.

Nearby categories

Adjacent product categories that share hazard patterns or regulatory oversight.

Data sources

Category data as of Jul 2, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 2, 2026.