Product category · Updated Aug 19, 2026

Medical Devices recalls

Name: Medical Devices Recalls
Creator: PlainRecalls
License: https://creativecommons.org/publicdomain/zero/1.0/

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. · Updated October 2026

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 · 2026-10-01

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-10-01.

Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

Category	Recalls	Vol %ile	Classified	Class I	Class I %	Rate %ile
Medical Devices	41,070	100	40,763	3,653	9%	14
Food	25,513	86	25,222	11,676	46.3%	86
Drugs & Medications	14,473	71	14,417	1,508	10.5%	29
Children & Baby Products	4,017	57	2,483	352	14.2%	43
Dietary Supplements	2,018	43	1,993	466	23.4%	71
Meat & Poultry	1,672	29	1,672	1,145	68.5%	100
Cosmetics & Personal Care	1,388	14	1,289	203	15.7%	57

High severity

3,653
Moderate

36,361
Lower severity

1,056

FDA Devices

39,794
FDA Drug

934
CPSC

307
FDA Food

35

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 218 of 822

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 systems Catalog Number: PS2683

Randox Laboratories Ltd.

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 ethylene oxide sterilization processes

Steris Corporation

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

VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

Steris Corporation

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 Number: PS2682 Control Level 1

Randox Laboratories Ltd.

FDA Devices Moderate Jan 11, 2023

Detect Covid-19 Test Product/Model Number: 21205

Detect Headquarters

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

Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
Source: CPSC - Consumer Product Safety Commission Recalls
Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)

Category data as of Aug 19, 2026.

Compiled by PlainRecalls, Product Recalls Editorial Process · October 1, 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.

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346

VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425

VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893

ActiveAid 922, Shower/Commode Chair

VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051

PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049

ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786

PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841

ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046

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

ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407

VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702

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

TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000

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

Programmable Diagnostic Computer

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

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

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

PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631

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

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

Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302

PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065

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

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

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

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

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

ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373

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

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

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

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

API NIT1 NIT2 REAGENTS, CATALOG 70442

BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011

ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478

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

PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751

BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690

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

VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes

ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486

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

VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071

Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

Detect Covid-19 Test Product/Model Number: 21205

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources