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 223 of 822

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 of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

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 with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

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 Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 /

NuVasive Specialized Orthopedics, Inc.

FDA Devices Critical Dec 21, 2022

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

ARROW INTERNATIONAL Inc.

What to do with this

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 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

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 of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

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

DeRoyal BASIC NEURO PACK, REF 89-7523.16

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

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

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources