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Showing 41–60 of 11714 results

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Draeger, Inc.: Draeger Vapor 3000. Unheated, calibrated anesthetic vapor...

A certain component of affected devices was not delivered within specification and contained impurities.

FDANov 24, 2025Nationwide• Draeger, Inc.

Smith & Nephew, Inc.: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix...

Removal of affected lot of screws due to labeling error.

FDANov 24, 2025Nationwide• Smith & Nephew, Inc.

ICU Medical, Inc.: LifeShield Drug Library Management (DLM); LifeShield Infu...

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

FDANov 24, 2025Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: LifeShield Drug Library Management (DLM), LifeShield Infu...

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

FDANov 24, 2025Nationwide• ICU Medical, Inc.

Decaf Coffee Pods (Gimme Coffee) – undeclared caffeine (2025)

Undeclared Allergen

Undeclared caffeine

Class IIModerate

FDANov 24, 2025FL, IA, MD +7 more• Gimme Coffee, Inc.

Zen Cleanse Herbal Tea (Bell Industries) – salmonella risk (2025)

Potential Salmonella contamination

FDANov 24, 2025IN, MA, TX +1 more• Bell Industries LLC

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

FDANov 24, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Pecorino Romano Cheese (Wegmans) – listeria contamination (2025)

Product may be contaminated with Listeria monocytogenes.

Class IVery High

FDANov 22, 2025CT, DE, MD +7 more• Wegmans Food Markets, Inc.

Pecan Cranberry Holiday Bark (Carousel Candies) – undeclared wheat (2025)

Undeclared Gluten

Undeclared wheat

FDANov 21, 2025Nationwide• Silvestri Sweets Inc dba Carousel Candies

Unknown Manufacturer: Medline Hudson RCI Medium Concentration Oxygen Masks: ...

Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.

FDANov 21, 2025Nationwide

Roche Diagnostics Operations, Inc.: The Elecsys Anti-TSHR immunoassay is a three-step competi...

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

FDANov 21, 2025Nationwide• Roche Diagnostics Operations, Inc.

Cookie Butter Holiday Bark (Carousel Candies) – undeclared pecan (2025)

Undeclared Allergen

Undeclared pecan

FDANov 21, 2025Nationwide• Silvestri Sweets Inc dba Carousel Candies

Senna Leaves (Whole Herb Company) – salmonella risk (2025)

Potential contamination with Salmonella.

FDANov 21, 2025CA, NJ• The Whole Herb Company, Inc.

Bisoprolol/Hydrochlorothiazide Tablets (Glenmark) – Cross Contamination (2025)

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

FDANov 21, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

CareFusion 303, Inc.: BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation E...

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

FDANov 20, 2025Nationwide• CareFusion 303, Inc.

Medtronic Neuromodulation: Restore Clinician Programmer Application (CP App), Model ...

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

FDANov 20, 2025Nationwide• Medtronic Neuromodulation

Chaga Mushroom Supplement (A New Life Herbs) – misbranded product (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Ear Drops Herbal Supplement (A New Life Herbs) – misbranded product (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

Sinus Cap Herbal Supplement (A New Life Herbs) – misbranded (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IIModerate

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

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