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

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

40,910 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · NHTSA federal recall filings · 2026-08-25

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 530 of 819

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N323), IVD, REF 418602, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Pro…

Philips Electronics North America Corporation

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N331), IVD, REF 418675, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M

Medtronic

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N245), REF 413394, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN72), REF 413403, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN92), IVD, REF 414963, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombog…

Arrow International Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P642), IVD, REF 418604, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO S…

Medtronic

FDA Devices Moderate Jun 21, 2017

Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312

Medtronic

FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery NM/CT 570c X-ray system

GE Healthcare, LLC

FDA Devices Moderate Jun 21, 2017

USPACK-SUTURE KIT; Item Number: US1672

Medtronic

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N334), IVD, REF 418984, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N228), REF 413145, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage…

Merge Healthcare, Inc.

FDA Devices Moderate Jun 21, 2017

1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blu…

Arrow International Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN49), REF 412091, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system

GE Healthcare, LLC

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN77), REF 413434, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN65), REF 412608, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-XN05), REF 413230, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GR…

Medtronic

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P633), REF 414994, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Zimmer Biomet, Inc.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hi…

Medtest Holdings, Inc.

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

GE Healthcare Discovery Ml DR X-ray system

GE Healthcare, LLC

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

GE Healthcare Optima CT540 X-ray system

GE Healthcare, LLC

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N254), REF 413723, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.

Biomerieux Inc

FDA Devices Moderate Jun 21, 2017

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen…

Arrow International Inc

FDA Devices Moderate Jun 21, 2017

VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton.

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.

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.