Florida recalls
4503 federal recalls on file affecting Florida - 948 Florida-specific plus 3555 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-03FDA-DeviceFoundation MedicineClass IINationwideFoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
- 2025-12-03FDA-DeviceFoundation MedicineClass IINationwideFoundationOne CDx (F1CDx), RAL-0003 version 31.0
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
- 2025-12-03FDA-DeviceOlympusClass INationwideBrand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- 2025-12-03FDA-DeviceGlycarClass INationwideSJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
The impacted lot may not meet the required tensile strength specification.
- 2025-12-03FDA-DeviceGlycarClass INationwideSJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
The impacted lot may not meet the required tensile strength specification.
- 2025-12-03FDA-FoodJeni's Splendid Ice CreamsClass IIJeni's Passion Fruit Dreamsicle Ice Cream Bars, 3 FL OZ (89 ML)/9 FL OZ (266 ML), packaged 3 bars per retail carton with Item UPC: 850060644122, packed 8 retail cartons per case with Case UPC: 10850060644129
Undeclared allergens - wheat and soy
- 2025-12-03FDA-FoodNats NutsClass IINat's Nuts Cinnamon Whiskey Pecans, 4 oz.
Contains undeclared cashews
- 2025-12-03FDA-FoodMeriCalClass INationwideMember's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775
Potential contamination of Salmonella Richmond
- 2025-12-03FDA-DrugCA BotanaClass IIDr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IICLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIElixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIElixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IISugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIKarina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIGabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IISea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17
CGMP Deviations
- 2025-12-03FDA-DrugCA BotanaClass IIDoctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
CGMP Deviations
- 2025-12-03FDA-DrugFresenius KabiClass INationwideFamotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2025-12-03FDA-DrugMedical Products LaboratoriesClass IINationwideWalgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- 2025-11-26FDA-DeviceGreiner Bio-OneClass IIBrand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
- 2025-11-26FDA-DeviceMeridian BioscienceClass IIMeridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
- 2025-11-26FDA-DeviceMeridian BioscienceClass IIMeridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
- 2025-11-26FDA-DeviceAnatomy Supply PartnersClass IINationwideSAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-26FDA-DeviceAnatomy Supply PartnersClass IINationwideMixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-26FDA-DeviceAnatomy Supply PartnersClass IINationwideSAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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