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Showing 5361–5380 of 92420 results

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Diphenhydramine HCl 25mg 100ct (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Diphenhydramine HCl 25mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Dabigatran Etexilate 150mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC

Acetaminophen Regular Strength (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Acetaminophen Extra Strength 500mg (Akron Pharma) – Incorrect Tablet Imprint (2024)

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

FDADec 12, 2024Nationwide• Akron Pharma, Inc.

Force Forever Tablets (GNMart) – Undeclared Medications (2024)

Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.

FDADec 12, 2024Nationwide• GNMart LLC

Impella RP with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

FDADec 12, 2024Nationwide• Abiomed, Inc.

ACCOLADE DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

Cucumbers (Wholesale Produce) - Salmonella Risk (2024)

Cucumbers may be contaminated with Salmonella.

FDADec 12, 2024IL, IA, KS +6 more• WHOLESALE PRODUCE SUPPLY LLC DBA

DLP Pediatric Arterial Cannulae (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

FDADec 12, 2024Nationwide• Medtronic Perfusion Systems

Tutti-Frutti (Three Rivers) - Undeclared Coloring (2024)

Undeclared Allergen

Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.

Class IIModerate

FDADec 12, 2024CT, DE, MD +6 more• Shata Traders Inc.

Gillig Low Floor (Gillig) – Electric Mode Speedometer Failure (2024)

Gillig, LLC (Gillig) is recalling certain 2023 Low Floor diesel-hybrid transit buses. During vehicle operations in full electric vehicle (EV) mode, the odometer will not display accumulated mileage. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 101, "Controls and Displays."

NHTSADec 11, 2024Nationwide• GILLIG

HealthFirst Mail-In Monitoring System (HF Acquisition) – Envelope Printing Error (2024)

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

FDADec 11, 2024AL, AK, AZ +47 more• HF Acquisition Co LLC

AquaFlexFlow UF 500 Plus (Nuwellis) – Weight Mismatch Risk (2024)

Laceration Risk

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

FDADec 11, 2024Nationwide• Nuwellis Inc

Suzuki AN400 (Suzuki) – Fuel Hose Assembly Contact (2024)

Suzuki Motor USA, LLC (Suzuki) is recalling certain 2023-2025 Burgman 400 (AN400AM3-M5) scooters. The fuel supply hose assembly may contact the fuel vapor hose assembly, causing the fuel supply hose to become damaged and leak fuel.

NHTSADec 11, 2024Nationwide• SUZUKI

LVIS Intraluminal Support Device (MicroVention) – Stent Deployment Issue (2024)

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

FDADec 11, 2024Nationwide• MICROVENTION INC.

Great Dane Champion (Great Dane) – Kingpin Weld Defect (2024)

Great Dane Trailers (Great Dane) is recalling certain 2025 Champion Dry Freight trailers. Missing kingpin welds may prevent the upper coupler from securely connecting the trailer.

NHTSADec 11, 2024Nationwide• GREAT DANE

OEC Technidot Air Brake Tubing (OEC) – Brake Line Defect (2024)

Advanced Technology Products, Inc (ATP) is recalling certain OEC/Technidot black 1/4" DOT air brake tubing with part numbers DOTA04ABK, DOTA04CBK, and DOTA04DBK. Sunlight exposure may cause the air brake tubing to crack and burst under pressure. As such, this equipment fails to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 106, "Brake Hoses."

NHTSADec 11, 2024Nationwide• OEC, TECHNIDOT

VidaSlim 90-day (Vidaslim Co.) – toxic yellow oleander (2024)

Due to the presence of Toxic yellow oleander

FDADec 11, 2024Nationwide• Vidaslim Co.

Daily Veggies Enoki Mushroom (New Age International) – listeria risk (2024)

may be contaminated with Listeria monocytogenes

FDADec 11, 2024MD, NY• New Age International, Inc.

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