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 · 2026-10-02

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 2026-10-02.

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 229 of 822

FDA Devices Moderate Nov 30, 2022

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

Smiths Medical ASD Inc.

FDA Devices Moderate Nov 30, 2022

B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

Medical Action Industries, Inc. 306

FDA Devices Moderate Nov 30, 2022

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 2, 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

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape

regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit

InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit

3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape

regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit

3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape

3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape

Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002

K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013

regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape

regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape

3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape

3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape

regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape

regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit

3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape

regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012

regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit

regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources