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
Compiled from official public sources by the editorial process.
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 215 of 819

FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

Programmable Diagnostic Computer

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay syst…

Randox Laboratories Ltd.
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and…

Steris Corporation
FDA Devices Moderate Jan 11, 2023

PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

Beaver Visitec International, Inc.
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

API NIT1 NIT2 REAGENTS, CATALOG 70442

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine mon…

Steris Corporation
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Numb…

Randox Laboratories Ltd.
FDA Devices Moderate Jan 11, 2023

Detect Covid-19 Test Product/Model Number: 21205

Detect Headquarters
FDA Devices Moderate Jan 11, 2023

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Medtronic MiniMed
FDA Devices Moderate Jan 11, 2023

PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

DeRoyal Tonsillectomy Tray, REF 89-10698.01

DeRoyal Industries Inc
FDA Devices Moderate Jan 11, 2023

BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.

Beckman Coulter, Inc.
FDA Devices Moderate Jan 11, 2023

VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100

Biomerieux Inc
FDA Devices Moderate Jan 11, 2023

API VP1 VP2 REAGENTS, CATALOG 70422

Biomerieux 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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

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.