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 · 2026-08-26

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 554 of 819

FDA Devices Moderate Mar 8, 2017

Basic Setup Pack, part number AMS1787(A Basic Setup Pack, part number AMS6519

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Basin Pack, part number AMS2497

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Upper Extremity Pack, part number AMS4670 Upper Extremity Pack, part number AMS4670(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Hystero Pack, part number PSS3535(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Catheter Pack, part number AMS4399(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external batter…

MED-EL Elektromedizinische Gereate, Gmbh

FDA Devices Moderate Mar 8, 2017

Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for int…

Cook Inc.

FDA Devices Moderate Mar 8, 2017

Lipo Pack, part AMS4420(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Ortho Minor Pack, part number AMS3710(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Lap/Pelviscopy Pack, part number PSS3256(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

D & C Pack, part number AMS4796(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access …

Cook Inc.

FDA Devices Moderate Mar 8, 2017

CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 …

Maquet Datascope Corp - Cardiac Assist Division

FDA Devices Moderate Mar 8, 2017

General Plastic Pack, part number PSS2432(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Bleph Pack, part number AMS3325(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Vein Tray, part number AMS6312

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Custom Pack - with Introducer Kit, part number TVS4011NI(L

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

ENT Pack, part number AMS3237(A ENT Pack, part number AMS4214

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Plastic Surgery Pack, part number AMS5685

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Head Pack, part number PSS1934(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PS…

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C …

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Total Joint Pack, part number 006358-6

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Custom Breast Augmentation Pack, part number PSS2455(D

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

Mckesson Medical Imaging

FDA Devices Moderate Mar 8, 2017

GYN Lap Pack, part number PSS2194(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Hand Pack, part number AMS3640 Hand Pack, part number AMS4213(A Hand Pack, part number AMS4311(A Hand Pack, part number AMS5343 Hand Pack., part …

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Peri GYN, part number PSS2193(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Set Up Pack, part number PSS3574(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Lumbar Laminectomy Pack, part number AMS2501 Lumbar Laminectomy Pack, part number AMS2501(A Lumbar Laminectomy Pack, part number AMS2501(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Basic Pack (1185), part number AMS6560

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Percutaneous Entry Kit, part number TVS4022(D Percutaneous Entry Kit , part number TVS4022(E Percutaneous Entry Kit, part number TVS4022(F

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Open Procedure Pack, part number AMS4596 Open Procedure Pack, part number AMS4596(A Open Procedure Pack, part number AMS4596(B

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Plastic Kit, part number CMP1084(C

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Dr Bragg Vein Tray - RX, part number 007912-8

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Facial Pack , part number AMS6501

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

BD AffirM VPIII Microbial Identification Test

Becton Dickinson & Co.

FDA Devices Moderate Mar 8, 2017

Plastic General Pack, part number AMS4215

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Extremity Pack-N Brunswick, part number PSS1866(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Brow Pack, part number PSS1785(C

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Angio Pack, part number AMS6711

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Morris Lap Pack, part number PSS3199(A

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Universal Pack, part number AMS2036

Windstone Medical Packaging, Inc.

FDA Devices Moderate Mar 8, 2017

Facial Plastic Pack, part number AMS3327(C

Windstone Medical Packaging, 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.