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

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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 · 2026-10-02

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 2026-10-02.

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 233 of 822

FDA Devices Moderate Nov 2, 2022

ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.

ConvaTec, Inc

FDA Devices Moderate Nov 2, 2022

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A

Siemens Healthcare Diagnostics, Inc.

Where Medical Devices sits among all 12 categories

Do more recalls mean more Class I danger?

Recalls in Medical Devices

ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599. For the management of stoma output following a colostomy or ileostomy procedure.

MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592

MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632

Medicina Oral Tip Syringe 0.5ml Code: OT005

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A

Medicina Oral Tip Syringe 2.5ml Code: OT25

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay

N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297

N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299

Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545

Medicina Reusable Oral syringe 5ml Code: OTH05

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

Medicina Oral Tip Syringe 1ml Code: OT01

Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

Medicina Reusable Oral syringe 2.5ml Code: OTH25

SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001

Medicina Reusable Oral syringe 1ml Code: OTH01

Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay

CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.

SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.

Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY

Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507

Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501

Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

Hobbs Posi-Stop Injection Needle Catalog Number: 4722

Hobbs Medical Grasping Forceps Catalog Number:5004

Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY

Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529

Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Hobbs Medical Cytology Brush Catalog Number: 4204

Freeman Pancreatic Flexi-Stent Catalog Number: 6533

Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.

Nearby categories

Food

Drugs & Medications

Vehicles

Children & Baby Products

Household Products

Dietary Supplements

Data sources