infant product Recalls

Olympus ViziShot 2FLEX Biopsy Device Recalled for Deformed Tips in 103,731 Units

Potential for undetected, deformed a-traumatic tips.

Glenmark Carvedilol 25 mg Recall Expands Over NNCI Impurity Above FDA Limit in 14,976 Bottles

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Hi-Tech Pharmaceuticals Joint-RX Dietary Supplement Recalled for Unapproved Drug Claims (2025)

Maquet Vasoview Hemopro 3 EVH System Recall Affects 98 Units, 16 Complaints of Out-of-Box Failures

Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.

M.O.M Enterprises Recalls 85,248 Organic BABY Bedtime Drops Over Spoilage Risk (2025)

Potential for spoilage due to yeast contamination.

Boston Scientific Encore 26 Inflation Device Recalled Over Foreign Particle Contamination

Haleon US Recall: Sensodyne PRONAMEL Active SHIELD Toothpaste Recalled for Label Mix-Up

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)

Boston Scientific NephroMax Kit Recall Covers 458 Units Over Foreign Material Migration Risk

Tandem Diabetes Care Recalls 122,958 t:slim X2 and Tandem Mobi Pumps Over Autobolus Risk (2025)

AVID Medical CPT BASIC IR PACK 1646381 Recall for Sterility Risk (2025)

AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer instructions.

B. Braun 23,100 0.9% Sodium Chloride Injection Containers Recalled for Sterility Concerns (2025)

B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.

B. Braun Medical Lactated Ringers Injection Recall for Sterility Concerns Affecting 74,088 Units (US

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Hospira Epinephrine Injection Vials Recalled for Lack of Sterility Assurance (2025)

Lack of Assurance of Sterility.

Hospira Sodium Bicarbonate Vial Recall for Sterility Concerns Affects 15,750 Vials

Lack of Assurance of Sterility.

AVID Medical JACK421-04 ENT PACK Recalled for Sterility Risk (2025)

AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.

Beckman Coulter DxC 500i Clinical Analyzer Modules Recalled for Processing Delays (2025)

Tegu Recalls 2 Magnetic Floating Stackers for Magnet Ingestion Hazard (2025)

KidKraft Backyard Kids Farm to Table Play Kitchen Recall 2025 After Strangulation Hazard

Waldemar Link Recall Reaches 8 Units of LinkSymphoKnee Tibial Components Over Uncoated Screws (2025)

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.