PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
Top agency
FDA Devices
Years covered
2000–2026
Compiled from official public sources by the publisher.
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-02

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 730 of 822

FDA Devices Moderate Apr 16, 2014

10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or e…

Remington Medical Inc.
FDA Devices Moderate Apr 16, 2014

Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

Tuberculosis Antibody Test Card Serum; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound d…

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Troponin I test Card (serum); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qual…

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Apr 16, 2014

Tramadol Test Card; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the packa…

Energizer Personal Care
FDA Devices Moderate Apr 16, 2014

Rotavirus Test Card LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic t…

Smiths Medical ASD, Inc.
FDA Devices Moderate Apr 16, 2014

PCP Test Card; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 9…

Intuitive Surgical, Inc.
FDA Devices Moderate Apr 16, 2014

Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Drugs of Abuse Panel Test Device; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Morphine Test Card (2000); LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

Central Purchasing LLC DBA Harbor Freight Tools
FDA Devices Moderate Apr 16, 2014

Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 9…

Intuitive Surgical, Inc.
FDA Devices Moderate Apr 16, 2014

Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

K2 (synthetic Marijuana) Test card; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb …

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentat…

Alcon LenSx, Inc.
FDA Devices Moderate Apr 16, 2014

GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage…

DePuy Orthopaedics, Inc.
FDA Devices Moderate Apr 16, 2014

Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

Barbiturate Test Card; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

Breg Inc
FDA Devices Moderate Apr 16, 2014

Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics Inc.
FDA Devices Moderate Apr 16, 2014

15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage

Aspen Surgical Products, Inc.
FDA Devices Moderate Apr 16, 2014

Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054

LumiQuick Diagnostics 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.