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 221 of 822

FDA Devices Moderate Dec 21, 2022

HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505

Stradis Medical, LLC dba Stradis Healthcare

FDA Devices Moderate Dec 21, 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 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

DeRoyal MYELOGRAM PACK, REF 89-9304.05

DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11

STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

DeRoyal VIT RD PACK 86ST, REF 89-7308.09

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

DeRoyal FOOT PACK, REF 89-9252.08

DeRoyal PAIN TRAY, REF 89-10464.03

HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089

DeRoyal SHOULDER KIT, REF 89-9497.08

DeRoyal CANNULTED HIP PACK, REF 89-6977.10

DeRoyal TRANS CANAL PACK, REF 89-7157.12

DeRoyal FACIAL PACK PGYBK, REF 89-10007.03

DeRoyal CATARACT PACK CSM, REF 89-6863

STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,

HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482

DeRoyal KIT HEART B PACK, REF 89-9042.07

DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02

DeRoyal SHOULDER PACK, REF 89-9449.13

HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15

DeRoyal KIT EXTREMITY PACK, REF 89-8869.09

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10240.03

DeRoyal RETINAL PACK, REF 89-7336.07

STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,

BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09

HENRY SCHEIN, Basin Set, Item No.570-1803

GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09

HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505

DeRoyal LAPAROSCOPIC ROBOTIC TRAY, REF 89-7063.11

DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10

DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02

DeRoyal HAND PACK, REF 89-10314.02

HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787

GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13

DeRoyal MYELOGRAM PACK, REF 89-9304.06

STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

DeRoyal PEDI ORTHO PACK, REF 89-5323.20

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

HENRY SCHEIN, Vas Pack, Item No.888-2520,

STRADIS HEALTHCARE, Phleb, Item No.682-1425,

HENRY SCHEIN, Labiaplasty PackItem No.570-3118,

HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources