Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Omnipod | Device intended for the subcutaneous delivery of insulin into a patient | Medical Devices | Manufacturing issue that could result in under delivery of insulin | Insulet Corporation, Inc. | … Omnipod … Insulet Corporation, Inc. … ACTON, Mass.--(BUSINESS WIRE)-- Insulet … by this correction represent approximately 8.5% of 2025 global Omnipod Pod production. Globally, there have been 24 reports of serious adverse … | ||
| Omnipod | Alternate controller enabled insulin infusion pump | Medical Devices | Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended. | Insulet Corporation | … Omnipod … Insulet Corporation … Medical Device Correction impacts only specifc … remain safe to use ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (“Insulet” or the “Company”) … approximately 1.5% of annual Omnipod® 5 pod production globally. Insulet continues to manufacture and ship Omnipod® … | ||
| Olympus | ViziShot 2 FLEX (19G) EBUS -TBNA needles | Medical Devices | Device & Drug Safety - Defect | Olympus Corporation | … Olympus … Olympus Corporation … CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX … | ||
| Olympus | Bronchofiberscopes and bronchovideoscopes | Medical Devices | Potential for endobronchial combustion | Olympus Corporation | … Olympus … Olympus Corporation … CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further … | ||
| Olympus | ViziShot 2 FLEX (19G) EBUS -TBNA needles | Medical Devices | Device Components May Detach During Procedures | Olympus Corporation | … Olympus … Olympus Corporation … CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX … lots to Olympus by following instructions provided in the global medical device removal action communication. Further, … | ||
| enVista Aspire | enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses | Medical Devices | Increased frequency of reports of toxic anterior segment syndrome | Bausch + Lomb Corporation | … enVista Aspire … Bausch + Lomb Corporation … Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see … | ||
| Diamond Shruumz | Infused Cones, Chocolate Bars, and Gummies | Food & Beverages | Toxic levels of muscimol | Prophet Premium Blends | … Smoke Shop 8436 Denton Hwy, Suite 205 Watuga TX 76148 Global Chaos Smoke Shop 8945 Hwy 6 N, Suite 280 Houston TX … New York NY Elevated Smoke Shop 7 Kelly Dr Cheektowaga NY Global Smoke Shop 1160 Mohawk St Utica NY Huntington Village … Rainier Ave S STE 1 Renton WA 98057 Tobacco City 2 Ek & JR Corporation 601 S Grady Way STE B Renton WA 98057 Smoke Town … | ||
| Mojo, Mojo 2, iQ 2, Phantom 2 | CPAP and BIPAP Masks with Magnets | Medical Devices | Potential interference with certain medical implants | Sleepnet Corporation | … Mojo, Mojo 2, iQ 2, Phantom 2 … Sleepnet Corporation … Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and … AM – 4:00 PM EST. Sleepnet has notified the FDA and other global regulators where required. Adverse reactions or … |