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 219 of 819

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

DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,

GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

DeRoyal EYE TRAY, REF 89-4957.08

DeRoyal SPINAL FUSION PACK, REF 89-7515.12

DeRoyal CUSTOM NEURO PACK, REF 89-7353.17

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14

HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08

NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

DeRoyal CATARACT PACK, REF 89-9241.04

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

DeRoyal CRANI PACK, REF 89-10202.03

NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

DeRoyal LAPINECTOMY PACK, REF 89-7198.11

STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

DeRoyal TOTAL HIP PACK, REF 89-9113.06

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)

DeRoyal TOTAL HIP PACK, REF 89-9113.07

DeRoyal PACEMAKER ICD PACK, REF 89-10902.01

DeRoyal SPINE PACK, REF 89-8361.08

HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890

DeRoyal KIT TOTAL HIP, REF 89-8861.07

STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,

DeRoyal CRANI PACK, REF 89-10202.05

HENRY SCHEIN, CATH PACK Item No.570-2789

NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

HENRY SCHEIN, OMFS, Item No.570-2779,

STRADIS HEALTHCARE, Vein, Item No.682-1732,

DeRoyal LUMBAR DISC PACK, REF 89-10590.02

STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

DeRoyal SPINE PACK, REF 89-8361.09

DeRoyal UNIVERSAL PACK, REF 89-9558.03

DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02

HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,

Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

DeRoyal CATARACT PACK, REF 89-9241.03

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

DeRoyal BIOPSY PACKPACK, REF 89-9756.05

STRADIS HEALTHCARE, Vein, Item No.682-577,

DeRoyal LUMBAR DISC PACK, REF 89-10605.02

DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13

DeRoyal PORT PACK PGYBK, REF 89-8748.05

GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources