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Showing 5041–5060 of 92420 results

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Crispy Crunch Ice Cream Cone (Lotte) – Undeclared Peanut (2025)

Undeclared Nuts

Undeclared peanut.

Class IHigh

FDAJan 10, 2025IN, OR, WA• Seoul Trading, Inc.

Granix Injection (Teva) – Failed Stability Test (2025)

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Class IIModerate

FDAJan 10, 2025Nationwide• Teva Pharmaceuticals USA, Inc

A820 myPTM Software (Medtronic) – App Interaction Delay (2025)

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

Moderate

FDAJan 9, 2025Nationwide• Medtronic Neuromodulation

CircuitGuard Bacterial Filter (Kung Shin) – Airflow Blockage (2025)

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

Very High

FDAJan 9, 2025Nationwide• Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan

Medline Convenience Kits (Medline) – Skin Barrier Issue (2025)

Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

Low

FDAJan 9, 2025CA, NY• MEDLINE INDUSTRIES, LP Northfield

CircuitGuard ThermoFlo (Kung Shin) – Airflow Blockage (2025)

Very High

FDAJan 9, 2025Nationwide• Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan

Soft Plum (AAHU BARAH) – Undeclared Sulfites (2025)

Undeclared Allergen

Product contains undeclared sulfites (4.66 mg/serving).

Class IIModerate

FDAJan 9, 2025CO, FL, GA +10 more• Global Commodities Inc

MSOT Acuity Echo (Ithera) – Safety Instruction (2025)

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Moderate

FDAJan 8, 2025Nationwide• Ithera Medical Gmbh Zielstattstr. 13 Munich Germany

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Low

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Low

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

ROMEO5 Red Dot Sights (SIG SAUER) – Ingestion Hazard (2025)

Fire/Burn Risk

This recall involves SIG SAUER ROMEO5 Red Dot Sights, Models SOR52001 and 7400579, which is a part included with Model SORJ53101. They are labeled with the SIG SAUER logo and ROMEO5 name on one side of the product. The model number can be found on the product packaging. The recalled dot sights contain either the letter K or M as the last digit of the serial number printed on the bottom of the sight. Sig Sauer will provide instructions on how to access the serial number. The optic sights come in the color black and with one packaged CR2032 button cell battery.

Very High

CPSCJan 8, 2025Nationwide

BD Pyxis MedBank (CareFusion) – Labeling Update (2025)

Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

Low

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

Pyxis MedStation (CareFusion) – Software Risks (2025)

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

High

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

BD Pyxis (CareFusion) – Medication Access Label (2025)

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

High

FDAJan 8, 2025Nationwide• CareFusion 303, Inc.

Stryker Precision Thin (Stryker) – Blade Measurement (2025)

Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Low

FDAJan 8, 2025Nationwide• Stryker Corporation

Children's Bike Helmets (Wemfg) – Head Injury Risk (2025)

This recall involves Wemfg's children's multi-purpose bike helmets. The helmets were sold in size small (S), fitting a head circumference of about 19-1/2 to 21-1/4 inches; and in the following multiple color combinations: blue/pink, green/blue, green/blue/purple, pink/blue/green, pink/purple/pink, pink/yellow/green, purple/pink/blue and purple/pink/yellow. All helmets have black padding, black straps and a black and red buckle. The helmets have a black and red plastic knob at the back of the helmet for adjusting the fitting. The model "MD-710-S" is printed on a white label on the inside of the helmet.

Low

CPSCJan 8, 2025Nationwide

Blue Bird All American Bus (Blue Bird) – Headlight Wiring (2025)

Blue Bird Body Company (Blue Bird) is recalling certain 2024-2025 All American school buses. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

High

NHTSAJan 8, 2025Nationwide• BLUE BIRD

Blue Bird All American Bus (Blue Bird) – Headlight Wiring (2025)

Blue Bird Body Company (Blue Bird) is recalling one 2025 All American transit bus. Due to incorrect wiring, the high and low beams are reversed, causing the high beam indicator to illuminate incorrectly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, "Lamps, Reflective Devices, and Associated Equipment."

High

NHTSAJan 8, 2025Nationwide• BLUE BIRD

Babyganics Sunscreen (Johnson) – Ingredient Separation (2025)

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Class IIModerate

FDAJan 8, 2025Nationwide• Johnson, S C and Son, Inc

Rapid fFN Specimen Tube (Hologic) – Collection Kit Issue (2025)

Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

High

FDAJan 8, 2025Nationwide• Hologic, Inc.

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