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 September 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 · 2026-09-28

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 2026-09-28.

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 177 of 822

FDA Devices Moderate Nov 1, 2023

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Moderate Nov 1, 2023

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

Maquet Cardiovascular, LLC

FDA Devices Moderate Nov 1, 2023

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Universal Meditech Inc.

FDA Devices Moderate Nov 1, 2023

Vasc. Open CVOR SJH, REF SJVO56B

American Contract Systems, Inc.

FDA Devices Moderate Nov 1, 2023

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Medtronic Sofamor Danek USA Inc

FDA Devices Critical Nov 1, 2023

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

EMPATICA SRL

FDA Devices Moderate Nov 1, 2023

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 · September 28, 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

Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010; Demineralized Bone Matrix

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z

PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

Vasc. Open CVOR SJH, REF SJVO56B

Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT; Demineralized Bone Matrix

Astral 100 and Astral 150 ventilators

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

Lem Fertility hCG Pregnancy Urine Test REF 100-12

DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

SOZO Bilateral Arm L-Dex Software

OMTMO One Step Ovulation (LH) Test Strips REF 200-07

Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack

One Step Pregnancy Test REF 100-01

HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10

CVS PCSU SJH, REF SJCV48J

Pediatric Heart SJH, REF SJPH34K

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

OPMI LUMERA 300, REF 6137

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis

Cath Cardiac Pack, REF IHCC03V

DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07

PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips

DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13

Robotics Pack, REF SSRO22D

DiagnosUS One Step LH Ovulation Test Strip REF 200-07

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack

HealthyWiser UriTest" UTI Test Strips REF 900-UTI

DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12

Sub Q Recorder Pack, REF BPRC87A

JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP

Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280; Demineralized Bone Matrix

DiagnosUS Ovulation Predictor Midstream REF 200-17

Breast Plastics Pack, REF BBPL20D

Lem Fertility LH Ovulation Test (Strip) REF 200-07

One Step Ovulation Test REF 200-01

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S

Centricity Universal Viewer Workflow Manager, Image processing radiological system

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources