fda regulated Recalls

689 recalls tagged with “fda regulated”.

Food & Beverages
HIGH
FDA FOOD

Pacific Coast Fresh CO Recalls King Harvest Spinach Hummus 2026 for Aluminum Fragments

Pacific Coast Fresh CO is recalling 239 containers of King Harvest Spinach Hummus sold in Oregon and Washington. Each 10-ounce tub bears UPC 025726311087 and Best By date 2/27/2026. Stop using the product immediately due to aluminum fragments and call Pacific Coast Fresh CO by telephone for refund or replacement.

Pacific Coast Fresh CO
Foreign material
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Food & Beverages
HIGH
FDA FOOD

King Harvest Black Olive Hummus Recalled for Aluminum Pieces in 319 Containers (2026)

King Harvest Black Olive Hummus, sold in 10-ounce plastic tubs and distributed in Oregon and Washington, is recalled after aluminum fragments were found. The recall cites a foreign material hazard. Consumers who purchased it should not consume it and should contact Pacific Coast Fresh CO by telephone for a refund or replacement.

Pacific Coast Fresh CO
Foreign material
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Health & Personal Care
HIGH
FDA DEVICE

Siemens Healthcare Diagnostics Atellica CH A1c_E Recall for 21,291 Units (2026)

Siemens Healthcare Diagnostics recalled 21,291 Atellica CH A1c_E units distributed to laboratories nationwide and internationally in 2026. The recall addresses a depressed result bias when A1c_E is processed with RCRP on the same analyzer. Labs using separate analyzers are not impacted. Stop using the affected module immediately and follow manufacturer instructions. Contact Siemens or your lab’s F

Siemens Healthcare Diagnostics
A potential
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Food & Beverages
HIGH
FDA FOOD

MEI HEONG YUEN Garlic Flavor Roasted Peanuts Recalled Over Cyclamate Ban in 2026

Mei Heong Yuen Garlic Flavor Roasted Peanuts, distributed by Super World Trading Inc., were recalled on Feb. 19, 2026. The products contain cyclamates, a banned sweetener. Consumers who purchased the product should not consume it and should contact the distributor for refund or replacement.

Mei Heong Yuen
Products contain
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Health & Personal Care
HIGH
FDA DRUG

Radnostix Sodium Iodide I-131 Gel Capsule Pack Recalled for 2,699 Units in 2026

Radnostix recalled 2,699 gelatin capsule packs used with its Sodium Iodide I-131 kit, distributed nationwide in the United States and Puerto Rico. The capsules failed to meet tablet/capsule specifications. Healthcare providers and patients should stop using the product and contact Radnostix for guidance.

SODIUM IODIDE I-131
Failed Tablet/Capsule
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Health & Personal Care
HIGH
FDA DEVICE

TECNIS Eyhance IOL with Simplicity Recall 361 Lenses (2026)

AMO Puerto Rico Manufacturing recalls 361 TECNIS Eyhance IOL with TECNIS Simplicity Delivery System lenses sold nationwide through healthcare providers. The lenses may have a haptic that sticks to the optic, preventing unfolding as expected. Patients and clinicians should stop using the device immediately and follow recall instructions.

AMO Puerto Rico Manufacturing
Due to
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Food & Beverages
HIGH
FDA FOOD

Sunflour Bakery Recalls 1 Bag Hamburger Bun Over Undeclared Sesame Seed (2026)

Sunflour Bakery recalled 1 bag of Hamburger Bun, 18oz with six buns sold to a single Orange County retailer. The recall involves sesame seeds not declared on the label. Consumers should not eat the product and should contact Sunflour Bakery by email for refund or replacement.

NRS Enterprises, Inc. dba Sunflour Bakery
Undeclared sesame
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Health & Personal Care
HIGH
FDA DEVICE

Baxter Recalls 19 Blue Volara Ventilator Adapters for Home Use (2026)

Baxter Healthcare recalled 19 Blue Ventilator Adapter Modules used with the Volara Respiratory Therapy system in Florida after an urgent correction flagged potential oxygen desaturation and barotrauma risks in home care. The correction provides home caregiver instructions for use. Patients and healthcare providers should stop using this device immediately and contact Baxter or a healthcare provide

Baxter
Urgent Medical
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Texas CPX 4 US Breast Tissue Expanders Recall 2026

Mentor Texas, LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs worldwide on February 18, 2026. The recall covers models SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH and SCPX-156MH. Infusion sets may include a dull needle tip that is difficult to advance and may break. Stop using the device and follow recall instructions from the manufacturer, with recall notification by-

Mentor Texas
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Mentor CPX 4 Breast Tissue Expanders Recalled in 2026 for Dull Needle Tip Hazard

Mentor Texas LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs on February 18, 2026. Infusion sets may have dull or blunt needle tips that can be difficult to advance or break. Health facilities and patients should stop using the device immediately and follow the recall instructions.

Mentor Texas LP
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Texas LP Recalls CPX 4 US Breast Tissue Expanders with Suture Tabs (2026)

Mentor Texas LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs sold worldwide, including US nationwide, after determining infusion sets may contain a dull needle tip. The defect may hinder needle advancement or cause breakage during use. Patients and providers should stop using the device immediately and follow recall instructions from the manufacturer.

Mentor Texas
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Texas Artoura Breast Tissue Expanders Recalled Worldwide in 2026

Mentor Texas, LP recalled Artoura Breast Tissue Expanders sold worldwide, including the United States. The infusion sets may contain a dull or blunt needle tip, which may be difficult to advance or break. Healthcare providers and patients should stop using the affected devices and await recall instructions by letter.

Mentor Texas
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Medline Sterile Radiology Procedure Kits Recalled for Sterility Breach (2026)

Medline Industries recalled 420 Sterile Radiology Procedure Kits, Model DYNDH1491B, distributed nationwide in Minnesota after a potential breach in sterile pouch packaging. The defect may compromise product sterility. Stop using the kit immediately and contact Medline or your healthcare provider for instructions.

Medline Industries, LP
There is
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Health & Personal Care
HIGH
FDA DEVICE

Abiomed Purge Cassette Recall 2026: 33,107 Impella Pump Sets Worldwide Over Purge Leaks

Abiomed has issued a Class I recall for 33,107 Purge Cassette units used with Impella pump sets worldwide due to purge leaks in Generation 1 cassettes. The leaks raise the risk of compromised device performance. Patients and healthcare providers should stop using the affected devices immediately and follow Abiomed's recall instructions.

Abiomed
Increased risk
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Artoura Breast Tissue Expanders Recall for Dull Needle Tips (2026)

Mentor Texas, LP is recalling Artoura Breast Tissue Expanders with infusion sets worldwide, including the United States and Canada. The infusion sets may contain dull or blunt needle tips that are difficult to advance or may break. Patients and healthcare providers should stop using the device and follow recall instructions.

Mentor
Infusion sets
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Health & Personal Care
HIGH
FDA DEVICE

Mentor Texas CPX 4 Breast Tissue Expander Recall 2026 for Dull Needle Tips

Mentor Texas, LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs sold worldwide, including the US. Infusion sets may have a dull or blunt needle tip that is difficult to advance or may break. Patients and healthcare providers should stop using the device immediately and contact Mentor Texas, LP for instructions.

Mentor Texas
Infusion sets
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