411 PRESS

FDA Recalls

Page 6 of 24 · 1,199 total recalls

Recalls — Page 6

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

Prazosin Hydrochloride Capsules

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...

Appco Pharma LLC
Warning
Packaged food on grocery store aisle shelves — representative photo for FDA food recall
Class II

Alain MILLIAT

Product may contain foreign objects, specifically glass.

FINESALER LLC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Pantoprazole Sodium

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have...

Hetero Labs Limited (Unit V)
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution CT ES

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution Ascend

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution Apex Select

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution Apex Elite

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution Apex

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution Apex Plus

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Revolution CT

GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...

GE Medical Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

Immy

Neutralization Buffer may contain contaminants

Immuno-Mycologics
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...

SUN PHARMACEUTICAL INDUSTRIES INC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...

SUN PHARMACEUTICAL INDUSTRIES INC
Warning
Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
Class II

Fluocinonide

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...

SUN PHARMACEUTICAL INDUSTRIES INC
Critical
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class I

VOCSN V+Pro package

Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under...

Ventec Life Systems
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

ZENBONE

Resorbable bone void filler falls outside standard specifications.

Orthorebirth Co Ltd
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

BioCera Fibers

Resorbable bone void filler falls outside standard specifications.

Orthorebirth Co Ltd
Warning
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class II

DEX Ophthalmic Tissue Forceps

Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping,...

Katalyst Surgical
Info
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class III

Heraeus, PALAMIX uno.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing...

Heraeus Medical GmbH (Dental Division)
Info
Hospital operating room medical equipment — representative photo for FDA medical device recall
Class III

Heraeus, PALAMIX duo.

Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing...

Heraeus Medical GmbH (Dental Division)

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