infant product Recalls

794 recalls tagged with “infant product”.

Health & Personal Care
HIGH
FDA DEVICE

Inpeco Recall: 8 FlexLab FLX Potassium Test System Units Over Unverified HIL Function (2025)

Inpeco recalled eight FlexLab FLX System Potassium Test System units sold in California and New York. The recall targets the Sample Integrity Module HIL function, which detects hemolysis, icterus and lipemia. The FDA has not evaluated this function for safety or effectiveness, risking erroneous results or delays. Labs should stop using the device immediately.

Inpeco
The FlexLab
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Recall Expands for Allura Xper FD20/15 OR Table Model 722059 (2025

Philips Medical Systems Nederland B.V. recalls 8 medical tables worldwide due to BIOS battery depletion risk. The recall affects Allura Xper FD20/15 OR Tables with model number 722059. The BIOS battery may deplete faster than expected, causing the system not to start without warning. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Blames BIOS Battery Design Flaw in Allura Centron 722400 Recall (Z

Philips Medical Systems Nederland B.V. recalls 313 Allura Centron devices with model 722400 worldwide after a BIOS battery drains too quickly. The issue can halt the system start-up with no user warning. The recall was issued September 3, 2025 and remains active as of October 8, 2025. Consumers should contact Philips or their healthcare provider for instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD10 Recalled for BIOS Battery Startup Failure (2,317 Units Worldwide, 2025)

Philips Medical Systems Nederland recalled 2,317 Allura Xper FD10 imaging systems worldwide, including 497 in the United States. The BIOS battery may deplete faster than expected, causing the startup process to halt with no user alerts. Hospitals should stop using the devices and await manufacturer instructions.

Philips Medical Systems Nederland
The BIOS
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland Recall: BIOS Battery Causes Startup Failures in Allura Xper CV20 7

Philips Medical Systems Nederland B.V. recalls 53 units of the Allura Xper CV20 system due to a BIOS battery that may deplete faster than designed. The recall affects units distributed worldwide, including the US and many other countries. The failure prevents system startup with no prior warning messages.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS
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Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Sulfamethoxazole and Trimethoprim 800 mg/160 mg 100-Tablets Recall 2025

Major Pharmaceuticals recalls sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets sold nationwide. A specific lot of packaging coil used in production was found to contain a microorganism in the packaging area, though no microorganism was detected on the tablets. Consumers should stop using the product and follow guidance from Major Pharmaceuticals or their healthcare provider.

Sulfamethoxazole and Trimethoprim
Presence of
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Health & Personal Care
HIGH
FDA DEVICE

LeMaitre Vascular Artegraft Collagen Vascular Grafts Recall 2025: 28 U.S. Units Affected

LeMaitre Vascular recalled 28 Artegraft Collagen Vascular Grafts distributed nationwide in 17 states. The grafts use bovine carotid arteries sourced from a supplier not reviewed by the appropriate regulatory authority. Patients and healthcare providers should stop using the device immediately and contact LeMaitre Vascular for instructions.

LeMaitre Vascular
The bovine
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Health & Personal Care
HIGH
FDA DRUG

Fagron Compounding Services Bevacizumab Syringe Recall Affects 109,320 Units Nationwide

Fagron Compounding Services recalls 109,320 sterile single-dose bevacizumab syringes nationwide due to lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately. Contact Fagron Compounding Services or a healthcare provider for guidance. The recall was issued on 2025-08-29 and remains active as of 2025-09-24.

Fagron Compounding Services
Lack of
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter Recall 2026

Northeast Scientific recalled 141 units of the NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter nationwide in the United States. The device may have breaches in the sterile barrier packaging that could compromise sterility. Hospitals and patients should stop using the device immediately and await instructions from Northeast Scientific Inc. or their clinicians.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare Recalls 136,512 CLEARLINK IV Sets DUO-VENT for Leak Risk (2025)

Baxter Healthcare recalled 136,512 CLEARLINK System Solution Set DUO-VENT IV sets distributed nationwide in the United States after detecting a leak risk. The Luer Activated Valve design may leak, potentially compromising IV administration. Hospitals and patients should stop using the device immediately and follow Baxter recall instructions.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Recall 2025

Northeast Scientific recalled 795 NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheters nationwide. The device is not cleared for marketing in the United States. The recall cites breaches in sterile barrier packaging that could compromise sterility. Hospitals and providers should stop using the device immediately and follow manufacturer instructions.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Laser Atherectomy Catheter Recalled for Sterile Barrier Breach Risk (2025)

Northeast Scientific recalled 165 units of the NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter sold nationwide in the United States. The recall cites the potential breach of sterile barrier packaging that could compromise sterility. The device is not cleared for marketing in the U.S. and has a high-risk hazard designation. Patients and healthcare providers should stop using the产品,

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Healthcare CLEARLINK CONTINU-FLO IV Set Recalled for Leaks in 2025 (958,351 Units)

Baxter Healthcare Corporation recalled 958,351 CLEARLINK CONTINU-FLO IV sets due to a leak risk. The non-vented sets feature three Luer activated valves and a Backcheck Valve. Distribution covered nationwide in the United States. Healthcare providers and patients should stop using the device immediately and follow recall instructions on the recall notice.

Baxter Healthcare
IV sets
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalled 1,019 Reprocessed Turbo Elite Atherectomy Catheters Over Sterility Bre

Northeast Scientific Corp. recalled 1,019 units of the NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. The model is not cleared for marketing in the United States. The recall cites potential breaches in sterile barrier packaging that could compromise sterility. Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Northeast Scientific Recalled 561 Units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy C

Northeast Scientific recalled 561 units of NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. The recall covers all lots within shelf life ending before August 29, 2026. The hazard is breaches in sterile barrier packaging that could compromise sterility. Stop using the device and follow manufacturer instructions for return or replacement.

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter Recall: 616 Units In US Distribution

Northeast Scientific Inc. has issued a recall for 616 units of the NES Reprocessed Turbo-Elite Laser Atherectomy Catheter, Model R-417-156. The FDA-listed recall cites breaches in sterile barrier packaging that could compromise sterility. The devices were distributed nationwide in the United States to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Patients should not be in

Northeast Scientific
Potential for
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Extractor Pro RX Balloon Catheter Recalled Over Labeling Error (2025)

Boston Scientific recalled 156 units of the Extractor Pro RX Retrieval Balloon Catheter nationwide in the United States after labeling inconsistencies were found. The label misstates whether the skive hole is above or below the balloon. The recall is active as of 2025. Stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The product
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