immediate action Recalls

2,660 recalls tagged with “immediate action”.

Food & Beverages
HIGH
FDA FOOD

Gina Marie Bakery Italian Sesame Cookies Recalled for Undeclared Sesame and Food Colorings (2025)

Gina Marie Bakery LLC recalled 172 cases of Italian Sesame Cookies after discovering undeclared sesame and artificial colorings. The recall began with CT state actions and was notified to FDA on 09/10/2025 with customer notification on 09/11/2025. Consumers should not eat these cookies and should seek refunds or replacements.

Gina Marie Bakery
Undeclared Sesame,
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Health & Personal Care
CRITICAL
FDA DEVICE

Abbott TactiFlex Sensor Ablation Catheter Recall 2025 Affects 1,958 Units

Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters worldwide. A limited number of tip detachment events occurred during catheter removal from packaging. Patients and healthcare providers should stop using the device immediately and follow Abbott's recall instructions.

Abbott
Abbott has
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Health & Personal Care
HIGH
FDA DEVICE

Biomet Juggerknot Mini Soft Anchors 912080 Recall 40 Units Nationwide 2025

Biomet recalled 40 Juggerknot Mini Soft Anchors, model 912080, distributed nationwide in the United States. The outer carton label lists JuggerKnot 1.0mm Mini devices, but the cartons contain JuggerKnot 1.4mm Short devices. Patients and clinicians should stop using the device and follow the recall instructions provided by Biomet.

Biomet
The outer
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Health & Personal Care
HIGH
FDA DEVICE

NOXBOX NOxBOXi Nitric Oxide Delivery System Recalled for 1,667 Units in 2025

NOXBOX LTD recalled 1,667 NOxBOXi Nitric Oxide Delivery System units distributed in Tennessee after reports of flow and dose fluctuations. The device can show fluctuations when the total flow through its sensor drops below 0.5 LPM. Dose fluctuations have been observed with LifePulse HFJV or conventional ventilators under certain settings. Stop using the device immediately and follow the recall. NO

NOXBOX
Fluctuations may
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Health & Personal Care
HIGH
FDA DEVICE

NOXBOX Recalled 1,667 NOxBOXi Nitric Oxide Delivery System Units in 2025

NOXBOX recalled 1,667 NOxBOXi Nitric Oxide Delivery System units sold in Tennessee. The recall was issued Sept. 9, 2025. An internal fault can occur when users press the interface rapidly without waiting for the device to respond. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.

NOXBOX
The unexpected
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Food & Beverages
HIGH
FDA FOOD

Hale recalls 54 bottles of Lotsa Pasta Roasted Garlic Infused Olive Oil for botulism risk (2025)

Hale Inc. recalls 54 bottles of Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil sold in Kentucky after concerns of Clostridium botulinum contamination. The product was manufactured without an approved processing. Consumers who purchased the oil should not consume it and should contact Hale Inc for refund or replacement.

Hale
Potential to
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Health & Personal Care
HIGH
FDA DEVICE

BioPro Endo Head Ceramic Recall Affects 147 Units Over Sterility Packaging Issue (2025)

BioPro recalled 147 Endo Head Ceramic implant components distributed in Texas and Michigan after packaging could compromise the sterile barrier. The defect could result in loss of sterility of the device, creating an infection risk if implanted. Clinicians and patients should stop using the devices and contact BioPro for instructions and refunds.

BioPro
Potential packaging
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Health & Personal Care
HIGH
FDA DEVICE

BioPro Femoral Head Hip Implant Recall 147 Units in 2025 Texas and Michigan

BioPro recalled 147 BioPro Femoral Head hip implant components sold in Texas and Michigan after a packaging defect could compromise sterility. The defect may result in loss of sterility, creating a risk of infection if implanted. Hospitals and clinicians should stop using the devices and await manufacturer instructions.

BioPro
Potential packaging
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Health & Personal Care
HIGH
FDA DEVICE

MedicalCommunications GmbH Recalls 474 Ashvins HEYEX 2 / HEYEX PACS Software Units (2025)

MedicalCommunications GmbH recalled 474 Ashvins HEYEX 2 / HEYEX PACS software units distributed nationwide in the United States. The affected software versions range from 2.6.0 (Build 2088) to 2.6.8 (Build 2220). The hazard is that the measured value may be smaller than the actual area, potentially affecting imaging measurements. Stop using the software immediately and follow manufacturer recall‑s

MedicalCommunications
Potential that
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Health & Personal Care
HIGH
FDA DEVICE

Draeger Atlan A350XL Anesthesia Workstation Recalled for Ventilator Failure Risk (223 Units) in 25+N

Draeger recalls 223 Atlan A350XL anesthesia workstations distributed in 25 states and many countries after reports of piston ventilator failure and mechanical ventilation failures. The recall affects units imported from Draegerwerk AG and Co. KGaA. Stop using the device immediately. Contact Draeger for instructions and patient safety guidance.

Draeger
The device
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Health & Personal Care
HIGH
FDA DEVICE

BioPro Recalls Bipolar Heads Over Sterility Risk

BioPro recalled 147 bipolar heads on September 9, 2025, due to a potential packaging issue. The defect may compromise the sterile barrier, increasing infection risks if implanted. Healthcare providers and patients should stop using these devices immediately.

BioPro
Potential packaging
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Food & Beverages
HIGH
FDA FOOD

Hale Fresh Basil Infused Olive Oil Recall: 54 Bottles in Kentucky (2025)

Hale recalled 54 bottles of Fresh Basil Infused Olive Oil sold in Kentucky after a recall notice citing potential botulism contamination. The FDA enforcement report H-0241-2026 documents the issue. Consumers should not consume this product and should contact Hale for refunds or replacements.

Hale
Potential to
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Health & Personal Care
HIGH
FDA DEVICE

Draeger Atlan A350 Anesthesia Workstations Recalled for Ventilator Failures in 2025

Drӕager recalled 530 Atlan A350 anesthesia workstations imported from Draegerwerk AG and Co. KGaA and distributed to 25 U.S. states and more than 30 countries. The device can experience a piston ventilator failure before use or fail to ventilate during use. Hospitals should stop using affected units immediately and follow Draeger recall instructions.

Draeger
The device
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