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 221 of 819

FDA Devices Moderate Dec 21, 2022

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear acc…

Siemens Medical Solutions USA, Inc

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

STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,

HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09

DeRoyal FOOT PACK, REF 89-9252.07

ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear acc…

STRADIS HEALTHCARE, Breast, Item No.693-276,

ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray

DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

STRADIS HEALTHCARE, Medical Vein, Item No.682-330,

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10

DeRoyal NEURO PACK, REF 89-9253.07

DeRoyal HAND PACK, REF 89-10314.03

STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,

DeRoyal PAIN TRAY, REF 89-10464.02

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump

DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13

GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02

STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,

DeRoyal CARDIAC LINEN PACK, REF 89-10543.02

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump

HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,

DeRoyal SHOULDER PACK, REF 89-9449.12

DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump

HENRY SCHEIN, Basin Pack, Item No.570-1692

DeRoyal BIOPSY PACK, REF 89-9270.04

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump

DeRoyal FOOT PACK, REF 89-9252.06

STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental

STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray

DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09

DeRoyal LAMINECTOMY PACK, REF 89-10209.02

DeRoyal PODIATRY PACK, REF 89-8359.10

DeRoyal PACEMAKER ICD PACK, REF 89-10216.06

DeRoyal NEURO PACK, REF 89-10171.03

DeRoyal BIOPSY PACK, REF 89-9614.07

HENRY SCHEIN, ENT PACK, Item No.570-2718

GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02

HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611

DeRoyal BIOPSY PACK, REF 89-9739.06

Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

DeRoyal BASIC EYE PACK, REF 89-9233.08

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

Oncentra Brachy radiation therapy planning system software.

STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04

NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01

GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources