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 220 of 819

FDA Devices Moderate Dec 21, 2022

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 21, 2022

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use w…

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Dec 21, 2022

DeRoyal BASIC NEURO PACK, REF 89-7523.16

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06

DeRoyal Industries Inc

FDA Devices Moderate Dec 21, 2022

NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numb…

NuVasive Specialized Orthopedics, Inc.

FDA Devices Critical 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 LUMBAR FUSION PACK, REF 89-10211.05

STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,

HENRY SCHEIN, VEIN TRAY, Item No.570-2738,

STRADIS HEALTHCARE, Angio Pack, Item No.686-199,

STRADIS HEALTHCARE, Lipo, Item No.681-254,

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement…

DeRoyal LAMI/CRANI PACK, REF 89-10787.01

HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742

DeRoyal SPINAL FUSION PACK, REF 89-7515.13

DeRoyal HEART PACK, REF 89-8351.12

DeRoyal CRANI PACK, REF 89-10242.02

HENRY SCHEIN, Vein Clinics 1, Item No.570-1426

DeRoyal BASIC NEURO PACK, REF 89-7523.15

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04

GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02

GEO-MED BIOPSY TRAY, REF 89-8753.01

HENRY SCHEIN, RHINO PACK, Item No.570-3070

DeRoyal CATARACT PACK, REF 89-10040.01

DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01

DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02

DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.09

STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular

HENRY SCHEIN, Amnio Tray, Item No.570-3059,

DeRoyal GU PACK, REF 89-10665.03

DeRoyal BIOPSY PACK, REF 89-9739.05

DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03

Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump

BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray

DeRoyal CATARACT PACK, REF 89-8650.10

Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray

HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930

DeRoyal CATARACT PACK, REF 89-8859.08

HENRY SCHEIN, Knee Pack, Item No.570-2908,

DeRoyal CNRV SPINAL PACK, REF 89-10532.03

DeRoyal HEART PACK, REF 89-8351.13

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use w…

DeRoyal BASIC NEURO PACK, REF 89-7523.16

DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06

NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numb…

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump

GEO-MED CATARACT PACK, REF 89-5790.08

DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02

DeRoyal TLIF PACK, REF 89-8780.04

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump

DeRoyal ACDF PACK, REF 89-8779.03

Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump

DeRoyal ORTHO SPINE BACK PACK, REF 89-7534.09

HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883

DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05

DeRoyal PODIATRY PACK, REF 89-8359.13

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources