Florida recalls
3971 federal recalls on file affecting Florida - 895 Florida-specific plus 3076 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-03FDA-DevicePivotal Health SolutionsClass IINationwideQuantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
- 2025-12-03FDA-DeviceRemelClass IINationwide1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Products may contain contamination, which may result in a darker or brown media color.
- 2025-12-03FDA-DeviceMagellan DiagnosticsClass IINationwideThe LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
- 2025-12-03FDA-DeviceDermaSensorClass IIDermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
- 2025-12-03FDA-DeviceStraumannClass IINationwideEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- 2025-12-03FDA-DeviceAlconClass IINationwideCONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25
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- 2025-12-03FDA-DeviceMedtronicClass IINationwideCatalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
- 2025-12-03FDA-DeviceOlympusClass IINationwideBrand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
- 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
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