Baxter Healthcare Corporation Recalls

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK Extension Set (Baxter) – Potential Leakage (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

CLEARLINK NON-DEHP Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

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NES 1.7mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

Getinge 88-Series Washer (Getinge) – Overheating Potential (2025)

Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

Moderate

FDAAug 29, 2025Nationwide• Getinge Disinfection Ab Ljungadalsgatan

CLEARLINK System Solution Set (Baxter) – IV Set Leak (2025)

IV sets may leak.

FDAAug 29, 2025Nationwide• Baxter Healthcare Corporation

NES 2.0mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

Frozen Raw Easy Peel Shrimp (Tas Tematic) – Nitrofuran Levels (2025)

Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed.

FDAAug 29, 2025CA, IN• Tas Tematic Foods Inc

Altec Service Body (Altec) – Cable Step Wire Risk (2023)

Altec Industries Inc. (Altec) is recalling certain 2011-2025 Aerial Device, Digger Derrick, and 2022-2025 Service Body vehicles. The cable step wire rope assembly may be improperly secured, which can allow the cable entry step to detach from the vehicle.

Moderate

NHTSAAug 29, 2025Nationwide• ALTEC

UV Germicidal Wand (BigTree) – Radiation Risk (2025)

The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.

FDAAug 29, 2025Nationwide• BigTree Sales Inc.

DuoDERM Dressings (ConvaTec) – Foreign Matter Risk (2025)

Wound dressing may have foreign matter on the product.

FDAAug 29, 2025Nationwide• ConvaTec, Inc

Midwest Fire All-Poly Series (Midwest Fire) – Hose Reel Mounting (2021)

Fire/Burn Risk

Midwest Fire Equipment & Repair Company (Midwest Fire) is recalling certain 2021-2025 All-Poly Series fire trucks. The hose reel mounting plate may crack and fail, which can cause the hose reel to detach from the vehicle.

NHTSAAug 28, 2025Nationwide• MIDWEST FIRE

RYOBI Pressure Washers (TTI) – Projectile Risk (2025)

This recall involves Ryobi brushless electric pressure washers, models RY142300 and RY142711VNM. The recalled pressure washers are green and have a spray nozzle, a detergent tank with a blue cap and storage for accessories. Ryobi is printed on the front of the unit. The model and following serial numbers can be found on the data plate located on the side of the motor housing: Model Number / Name Serial Number Range RY142300 - Electric 2300 PSI Pressure Washer EU17121D010001 through EU20256N180999 LT20211D140001 through LT21166D090999 RG22154D090001 through RG23182N140999 RY142711VNM - Electric 2700 PSI Pressure Washer LT21411D090001 through LT21425D090999 RG21411D010001 through RG23182N140999

CPSCAug 28, 2025Nationwide• TTI Outdoor Power Equipment, Inc. (TTIOPE), of Anderson, South Carolina

Exeter V40 Stem (Howmedica) – Product Mix Concern (2025)

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

FDAAug 28, 2025IN• Howmedica Osteonics Corp.

Sharesource Connectivity Platform (Vantive) – Software Prescription Error (2025)

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

FDAAug 28, 2025Nationwide• Vantive US Healthcare LLC

Aripiprazole Tablets (Ascend) – Superpotent drug risk (2025)

Superpotent drug

FDAAug 28, 2025Nationwide• Ascend Laboratories, LLC

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

FDAAug 28, 2025Nationwide• Boston Scientific Corporation

AlignRT InBore System (Vision RT) – Laser Information Omission (2025)

Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).

FDAAug 27, 2025Nationwide• Vision RT Ltd Dove House Arcadia Avenue London United Kingdom

PeriGuard Ointment (DermaRite) – CGMP contamination risk (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

FDAAug 27, 2025Nationwide• DermaRite Industries, LLC

4-N-1 Skin Protectant (DermaRite) – Manufacturing Contamination (2025)

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.