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

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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 · 2026-09-26

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 2026-09-26.

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 117 of 822

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.

Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

BiomarC EX Fiducial Marker System, Catalog Number 040165

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L

Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device

ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A

Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system

ViewPoint; system, imaging processing, radiological

Polaris Recalls Sportsman All-Terrain Vehicles Due to Fire Hazard

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064

Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.

Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.

25-LHP-928, HeNe Laser System, 25 mW

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

N-LHP-928, HeNe Laser System, 35 mW

Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799

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Data sources