FDA Recalls

Page 16 of 39 · 1,907 total recalls

Recalls — Page 16

Browse recalls by hazard or company.

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted...

ARROW INTERNATIONALApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted...

ARROW INTERNATIONALApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Cannon II Plus Hemodialysis Catheter

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted...

ARROW INTERNATIONALApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

NextStep Antegrade Chronic Hemodialysis Catheter

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted...

ARROW INTERNATIONALApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Codman CerebroFlo EVD Catheter with Endexo Technology

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Integra LifeSciences Corp. (NeuroSciences)Apr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Critical

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class I

Medline kits containing Huons Co

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was...

Medline IndustriesApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic Tip Steerable, Product Number 6DYNTP001

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Incomplete seals on sterile product

Stryker Sustainability SolutionsApr 10, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be

Due to nonconforming products being inadvertently distributed.

Stryker CorporationApr 9, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

Omega-3-Acid

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on...

The Harvard Drug Group LLCApr 9, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

Desmopressin Nasal Spray

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

Apotex Corp.Apr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

Revitaderm Wound Care

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be...

Blaine Labs IncApr 8, 2026

Critical

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class I

Revitaderm Wound Care Gel

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and...

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

TERPENICOL Antifungal Cream (Undecylenic Acid 13%)

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

TERPENICOL Antifungal Solution

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be...

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs IncApr 8, 2026

Warning

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall

Class II

vite20 Antifungal Cream

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Blaine Labs IncApr 8, 2026

Warning

Hospital operating room medical equipment — representative photo for FDA medical device recall

Class II

3DIMENSIONS MAMMOGRAPHY SYSTEM

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

HologicApr 8, 2026

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