Safety Alerts |

FDA Warning High Priority

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes…

Nov 3, 2025

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FDA Warning High Priority

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE…

Nov 3, 2025

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Product Recall High Priority

Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes…

Oct 31, 2025

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Product Recall High Priority

Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 20 mEq Potassium Chloride Injection Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection

FOR IMMEDIATE RELEASE – October 31, 2025 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall to the user level, for a MISLABELLED lot of POTASSIUM CHLORIDE…

Oct 31, 2025

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Product Recall High Priority

First and Last Bakery, LLC Recalls First and Last Brand Tomato Sauce Products Because Of Possible Health Risk

First and Last Bakery, LLC of Hartford, CT, is recalling the following products due to a possible health risk identified by the Connecticut Department of Consumer Protection. • First and…

Oct 31, 2025

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FDA Warning High Priority

Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication

Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.

Oct 31, 2025

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Product Recall High Priority

Vanguard Enterprises, LLC. dba Bedrock MFG Recalls Monarch Premium Kratom Powder Because of Possible Health Risk

October 28, 2025, Vanguard Enterprises, LLC. DBA Bedrock MFG of Boise, Idaho is recalling Monarch Premium Kratom brand Bali Gold, Red Bali, Green Maeng Da, and White Elephant powder because…

Oct 30, 2025

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Product Recall High Priority

Supreme Produce LLC Voluntarily Recalls Moonlight Peaches Because of Possible Health Risk

Supreme LLC. (dba Supreme Produce) is notifying customers of a voluntary recall initiated by its supplier, Moonlight Companies, Moonlight Companies on white and yellow flesh peaches, due to potential contamination…

Oct 30, 2025

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Product Recall High Priority

New Hoque & Sons Inc Issues Alert on Uneviscerated “Dry Ghoinnya Fish”

New Hoque & Sons Inc. of Maspeth, NY, is recalling its packages of “Dry Ghoinnya Fish” because the product was found to be uneviscerated.The recalled “Dry Ghoinnya Fish” were distributed…

Oct 29, 2025

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Product Recall High Priority

Moonlight Companies Voluntarily Recalls California-Grown Conventional Yellow and White Peaches Because of Possible Health Risk

October 29, 2025 – Moonlight Companies is voluntarily recalling California-grown conventional yellow and white peaches because they have the potential to be contaminated with Listeria monocytogenes, an organism that can…

Oct 29, 2025

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Product Recall High Priority

Pacific International Marketing Recalls Fresh Italian Parsley Because of Possible Health Risk

Salinas, CA (October 28, 2025) - Pacific International Marketing (“Pacific”) is recalling 474 cases of bulk Italian Parsley because it may be contaminated with Salmonella, an organism that can cause…

Oct 28, 2025

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Product Recall High Priority

Purity Products Announces Recall on the Dietary Supplement, My Bladder Because of Possible Health Risk

Plainview, NY. October 27, 2025— Purity Products is announcing a recall of one lot of of its dietary supplement MyBladder because it has the potential to be contaminated with Escherichia…

Oct 28, 2025

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Product Recall High Priority

Homeneeds Inc. Recalls Devi Brand Ground Cinnamon (Dalchini Powder) Because of Possible Health Risk

10/27/2025, Homeneeds Inc. of Bellevue, WA is recalling 140/100gram packets of Devi brand Cinnamon Powder (Dalchini Powder), batch #2502315, because it has the potential to be contaminated with lead.

Oct 27, 2025

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Product Recall High Priority

Peterson Company Recalls Twin Sisters Creamery Brand Whatcom Blue and Farmhouse Cheese Products Because of Possible Health Risk

October 26, 2025, Peterson Company of Auburn, WA is voluntarily recalling Twin Sisters Creamery brand item# 28855 Whatcom Blue and item# 29608 Farmhouse Cheese products which were made from raw…

Oct 26, 2025

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Product Recall High Priority

E.A. Sween Company Announces Product Recall Due to Choking Hazard

E.A. Sween Company announced the recall of one of its products, due to the potential presence of foreign particles (plastic) within the product. Affected product involves the Deli Express® BBQ…

Oct 25, 2025

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Product Recall High Priority

Teasdale Latin Foods Issues Allergy Alert on Potential Undeclared Milk in Certain Taco Dinner Kits

Carrollton, TX — Teasdale Foods, Inc. is recalling certain Taco Dinner Kits, because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the…

Oct 25, 2025

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Product Recall High Priority

Zingerman’s Candy Manufactory Issues Allergy Alert on Undeclared Peanut & Cashew in Candy Bars

Zingerman’s Candy Manufactory of Ann Arbor, Michigan is recalling Zingerman’s Peanut Butter Crush Full Size Bars with Lot#174250 because it may contain undeclared cashew and Zingerman’s Ca$hew Cow Full Size…

Oct 24, 2025

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Product Recall High Priority

Aquastar (USA) Corp Recalls Shrimp Because of Possible Health Risk

October 17, 2025, AquaStar (USA) Corp of Seattle, WA is voluntarily recalling a limited quantity of frozen shrimp imported from Indonesia because they may have been prepared, packed, or held…

Oct 18, 2025

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Product Recall High Priority

Jody’s Inc. Recalls Cabot Creamery Sea Salt Caramel Cheddar Popcorn Due to Undeclared Peanuts CORRECTED UPC CODE

Jody’s Inc. is recalling Cabot Creamery Sea Salt Caramel Cheddar Popcorn 6 oz (170 g) bag, lot number 2519907B1, Best If Enjoyed By: 07 15 26 UPC 8 50016 94430…

Oct 17, 2025

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Product Recall High Priority

Haitai, Inc. Recalls Haetae (HT) Brand Cinnamon Powder 8 oz of Possible Risk

Haitai, Inc of Cerritos, CA (Oct., 15, 2025) is recalling Haetae (HT) brand Cinnamon powder 8 oz because it has the potential to be contaminated with lead.

Oct 17, 2025

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Product Recall High Priority

Nat’s Nuts Issues Allergy Alert on Potential Undeclared Cashews in Nat’s Nuts Brand Cinnamon Whiskey Pecans

Nat’s Nuts of Rochester, NY is recalling 600 bags of Cinnamon Whiskey Pecans, because they may contain undeclared cashews. People who have an allergy or severe sensitivity to cashews run…

Oct 17, 2025

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Product Recall High Priority

Kenz Henz Recalls "Pastured Raised Eggs" Because of Possible Health Risk

Kenz Henz of Santa Fe, TX, is recalling its 12 count packages of "Grade AA Large Pasture Raised eggs" because they have the potential to be contaminated with Salmonella, an…

Oct 16, 2025

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FDA Warning High Priority

Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication

FDA is aware of serious complications reported with certain uses of radiofrequency microneedling devices; asks for reports of injuries related these devices

Oct 15, 2025

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Product Recall High Priority

Publix Rich & Creamy Vanilla Ice Cream Voluntarily Recalled in Select Areas

Publix has initiated a voluntary recall on one lot of Publix Rich & Creamy Vanilla Ice Cream, UPC 41415 03043, that may contain an undeclared egg allergen. The product was…

Oct 14, 2025

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FDA Warning High Priority

Alert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed

Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller

Oct 10, 2025

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FDA Warning High Priority

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.

Oct 10, 2025

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FDA Warning High Priority

Trividia Health, Inc. Initiates Voluntary Recall of Limited Number of TRUE METRIX® Blood Glucose Meters

(FT. LAUDERDALE, FL) –October 7, 2025 – Trividia Health, Inc., announced today that it is initiating a voluntary recall of a limited number of TRUE METRIX® Self-Monitoring Blood glucose meters…

Oct 7, 2025

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FDA Warning High Priority

Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

Sep 30, 2025

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FDA Warning High Priority

What is a Medical Device Recall?

Sep 29, 2025

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FDA Warning High Priority

What is an Early Alert?

Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication

Sep 29, 2025

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