28
August
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Outbreak Investigation of E. coli – Leafy Greens (December 2020)
in FDA News
Outbreak Investigation of E. coli - Leafy Greens (December 2020) Read More (external link)...
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FDA News
28
August
Outbreak Investigation of E. coli O157:H7: Power Greens Packaged Salad (January 2022)
in FDA News
The FDA and CDC, in collaboration with state and local partners, investigated illnesses in a multistate outbreak of E. coli O157:H7. Read More (external link)...
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28
August
Outbreak Investigation of E. Coli O157:H7 – Spinach (November 2021)
in FDA News
Outbreak Investigation of E. Coli O157:H7 - Spinach (November 2021) Read More (external link)...
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28
August
Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
in FDA News
Tandem Diabetes Care, Inc. recalls t:connect mobile app (v2.7) for t:slim X2 insulin pump due to software issue that may cause app to crash and deplete pump battery Read More (external link)...
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26
August
Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins
in FDA News
Sunco & Frenchie LLC of Pine Brook, New Jersey is recalling its 10oz Terrafina Golden Raisins because they may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products Read More (external link)...
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26
August
2023 Safety Communications
in FDA News
Listing of Medical Device 2023 Safety Communications Read More (external link)...
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26
August
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication
in FDA News
A voluntary recall initiated by SoClean for use of SoClean2 and SoClean3 equipment to clean, sanitize or disinfect CPAP devices and accessories. Read More (external link)...
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23
August
Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks
in FDA News
Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclared milk and/or sesame were discovered during the FDA review of the product labels. People who have a Read More (external link)...
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23
August
Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk
in FDA News
Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp and Gutierrez brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead l Read More (external link)...
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23
August
Sierra Stain Recalls Tattoo Pigments Because of Possible Health Risk
in FDA News
Sierra Stain LLC of Carson City, Nevada is recalling 3 water-based tattoo pigments, because they are contaminated with high concentrations of microorganisms which present a health concern to consumers. Commonly reported symptoms of tattoo ink associated infections include the appearance of rashes or Read More (external link)...
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23
August
Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be Contaminated, Break, Leak, or Otherwise Fail
in FDA News
Syringes included in Medline Convenience Kits should not be used due to risk for contamination, breakage, or leakage. Read More (external link)...
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23
August
Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient Injury and Death from Device Entrapment and Pulmonary Emboli
in FDA News
ClotTriever XL is used to remove clots and blockages in large vessels. Inari is updating Use Instructions after reports of entrapment and pulmonary emboli. Read More (external link)...
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22
August
Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping Compressions
in FDA News
The RMU-2000 ARM XR Chest Compression Device provides external chest compressions. A motor issue may cause the device to unexpectedly stop. Read More (external link)...
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21
August
Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops
in FDA News
Unilever in the United States is recalling approximately 137,000 cases of Popsicle Jolly Rancher Frozen Confection Pop products (single serve offerings) because the products may contain milk, which is not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to milk Read More (external link)...
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21
August
Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth
in FDA News
Authentik Fudge of Sainte-Julie, Quebec, Canada, is recalling 840 units of Chocolate Fudge with Nuts branded MONTREAL FUDGE, due to potential mold growth contamination. Read More (external link)...
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20
August
Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
in FDA News
Sacramento CA, Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters packaged in a carton to the consumer level. Boulla LLC was notified by Amazon that the product was found to be tainted with sildenafil, an ingredient in FDA approved p Read More (external link)...
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20
August
Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil
in FDA News
Sacramento CA, Veata LLC is voluntarily recalling lot 230811, Exp 8/11/25 of Endurance Pro Energy Boost capsules, packaged in 10-count blisters ina cardboard carton to the consumer level. Veata LLC was notified by Amazon that the products were found to be tainted with sildenafil, an ingredient in FD Read More (external link)...
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20
August
Conspiracy and Fraud Charges Added Against Operator of Central California Bio-Lab and His Partner in Connection with Sale of Millions of Dollars in COVID-19 Test Kits
in FDA News
FDA-OCI, Central California, Fresno, California, Reedley, COVID-19 Test Kits, Jia Bei Zhu, Zhaoyan Wang Read More (external link)...
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20
August
2024 Medical Device Recalls
in FDA News
2024 Medical Device Recalls Read More (external link)...
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20
August
Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion System due to Diminished Battery Life that May Impact Infusion Delivery
in FDA News
If a Plum 360, A+ or A+3 pump is running on battery power with no AC backup, an ongoing infusion may be stopped when batteries unexpectedly run out. Read More (external link)...
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