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Showing 1041–1060 of 35905 results

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Doxycycline Hyclate Tablets 100mg (Acella) – Dissolution Failure (2025)

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Class IIModerate

FDASep 29, 2025Nationwide• Acella Pharmaceuticals, LLC

Brown Jumbo Eggs (Eggs Unlimited) – Salmonella Risk (2025)

Firm received, repackaged eggs that are potentially contamination with Salmonella.

FDASep 29, 2025CA, CT, IN +1 more• EGGS UNLIMITED LLC

Bona Fish (Vicky IT) – Contamination Concerns (2025)

Fish is un-eviscerated (may be contaminated with Clostridia botulinum), is contaminated with mold, and contains filth (insect larvae)

Class IHigh

FDASep 27, 2025NY• Vicky IT Inc.

Cheesy Cauliflower Au Gratin (FreshRealm) – Listeria Risk (2025)

Potential contamination with listeria monocytogenes

Class IIModerate

FDASep 27, 2025Nationwide• FreshRealm, Inc

AART Chin Implant (DSAART) – specification deviation (2025)

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDASep 26, 2025AZ, AR, CA +24 more• DSAART LLC

Carescape B450 Monitor (GE) – battery performance (2025)

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

FDASep 26, 2025Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

AART Malar Implant (DSAART) – specification deviation (2025)

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDASep 26, 2025AZ, AR, CA +24 more• DSAART LLC

MiraQ System (Medistim) – printer module failure (2025)

Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

FDASep 26, 2025CO, MI, MN +2 more• Medistim Asa Okernveien

SAFE-T-FILL Magnetic Rings (ASP) – manufacturing process (2025)

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

FDASep 26, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

SAFE-T-FILL Micro Capillary Collection (ASP) – manufacturing process (2025)

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

FDASep 26, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Portrait VSM Monitor (GE) – battery performance (2025)

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

FDASep 26, 2025Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

AART Calf Implant (DSAART) – specification deviation (2025)

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDASep 26, 2025AZ, AR, CA +24 more• DSAART LLC

Mixing Fleas for Blood Gas Capillaries (ASP) – manufacturing process (2025)

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

FDASep 26, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Phoenix Quick Liner (Phoenix) – Wheel Cover Attachment Issue (2025)

Medix Specialty Vehicles, Inc. (Medix) is recalling certain Phoenix Quick Liner Wheel Covers installed, with the clip-on feature, on Medix Ford Type-III ambulances. The wheel covers may detach during transit.

NHTSASep 26, 2025Nationwide• PHOENIX

CODMAN 11mm Disposable Perforator (Integra) – weld inadequacy (2025)

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

FDASep 26, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

CARESCAPE ONE Monitor (GE) – battery performance (2025)

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

FDASep 26, 2025Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

CODMAN 9mm Disposable Perforator (Integra) – weld inadequacy (2025)

Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

FDASep 26, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Locking Screw for IM Nail (Synthes) – packaging mislabel (2025)

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

FDASep 26, 2025Nationwide• Synthes (USA) Products LLC

SAFE-T-FILL Micro Capillary Collection (ASP) – manufacturing process (2025)

Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

FDASep 26, 2025Nationwide• ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Patient Monitors B105/B125/B155 (GE) – battery performance (2025)

Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

FDASep 26, 2025Nationwide• GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki Finland

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