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

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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 218 of 819

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 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

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

Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray

DeRoyal BASIC NEURO PACK, REF 89-7258.10

STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

DeRoyal TOTAL KNEE PACK, REF 89-9300.08

STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump

DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources