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

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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 214 of 822

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY

Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO

Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC

Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II

cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

Sterile Procedural Trays, labeled as the following: LS MS PACK

Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK

TRACH PACK. Sterile Procedural Tray.

Identity Shoulder System Resection Planer 35mm Resection Planer

ANCILLARY PACK-LF. Sterile Procedural Tray.

TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

Sterile Procedural Trays, labeled as the following: IM NAIL

Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY

Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST

cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.

Mammotome MammoStar Biopsy Site Identified, REF STAR1401

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.

NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.

CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24

Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

AxiEM" Non-Invasive Patient Tracker

Non-sterile procedural trays labeled as CRANI, 2 per case

Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources