PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

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

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.

  • 40,910 total recalls
  • #1 of 12 among categories
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.

40,910
total recalls
#1 of 12
category rank by events
9%
graded high-severity
FDA Devices
top issuing agency

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 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 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 303 of 819

FDA Devices Moderate Feb 17, 2021

Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection t…

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protect…

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8…

Baxter Healthcare Corporation

FDA Devices Moderate Feb 17, 2021

KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal S…

Argon Medical Devices, Inc

FDA Devices Moderate Feb 17, 2021

WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains.

Wahl Clipper Corp

FDA Devices Moderate Feb 17, 2021

Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian …

Arrow International Inc

FDA Devices Moderate Feb 17, 2021

Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns…

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier prote…

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency c…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminuti…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection …

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment o…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - Product Usage: Used with endoscopes to endoscopically remove stones such as calculi, pa…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile,…

ICU Medical, Inc.

FDA Devices Moderate Feb 17, 2021

CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier prote…

Cardinal Health 200, LLC

FDA Devices Moderate Feb 17, 2021

NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in t…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment …

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of es…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine nee…

Aomori Olympus Co., Ltd.

FDA Devices Moderate Feb 17, 2021

Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homec…

Arjohuntleigh Magog, Inc.

FDA Devices Moderate Feb 17, 2021

BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test i…

Becton Dickinson & Co.

CPSC No agency class Feb 11, 2021

Rep Fitness Recalls Strap Safety Brackets Due to Injury Hazard (Recall Alert)

FDA Devices Moderate Feb 10, 2021

Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIA…

Philips Ultrasound Inc

FDA Devices Moderate Feb 10, 2021

Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Us…

Philips Ultrasound 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 29, 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 29, 2026.