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 113 of 822

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.

Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

NxTAG Respiratory Pathogen Panel, REF: I051C0447

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.

Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.

DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01

DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01

Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.

DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

IntelliVue G7m Anesthesia Gas Module, Product Number 866173

MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851

Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Data sources