Product category · Updated Jul 29, 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: 40,910
Top agency: FDA Devices
Years covered: 2000–2026

Compiled from official public sources by the editorial process. · Updated August 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

High severity

3,645
Moderate

36,211
Lower severity

1,054

FDA Devices

39,635
FDA Drug

934
CPSC

306
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 226 of 819

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 Jul 29, 2026.

Compiled by PlainRecalls, Product Recalls Editorial Process · August 12, 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.

Recalls in Medical Devices

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

regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit

Unity Total Knee System. Used for knee prosthesis in total knee replacement

regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery convenience kit

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

Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO

regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenience kit

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

Hamilton-C6

regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit

regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit

Nearby categories

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Data sources