Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DrugsClindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
FDA FoodCinnamon, Clear Plastic Container, 100G, UPC 6251136 034139
Cinnamon, Clear Plastic Container, 100G, UPC 6251136 034139
Elevated levels of lead.
FDA DevicesMedline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
FDA DevicesDetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
FDA DevicesPhilips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
FDA DrugsPetroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA FoodUkrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses NET WT 30 OZ (2.06lb/936g) UPC 7 22515 91452 7 and Ukrop's 8" Pound Cake with Buttercream Icing/Red Roses NET WT 44 OZ (2.75lb/1.25kg) UPC 7 22515 91456 5 CONTAINS: Egg, Milk, Wheat Made in a production area that also uses soy and tree nuts. Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Undeclared Soy. Label did not include soy, which was used in product.
FDA DrugsTESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA DevicesBD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Labeling error, Incorrect expiration date
FDA FoodTops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances - Strawberry. Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626322 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Tops Strawberry Jam INGREDIENTS: Sugar, Strawberry Pulp 30%, Gelling Agent (Pectin - INS 440), Acidity Regulator (Citric Acid - INS 330), Preservative (Sodium Benzoate - INS 211, Potassium Metabisulphite - INS 224), Food Colour (Carmoisine - INS 122), Nature Identical Flavouring Substances - Strawberry. Allergen Advice: Contains Sulphite, May Contain Soy & Wheat. PRODUCT OF INDIA Brand Owned & Mktd. by: G.D. Foods Mfg. (I) Pvt. Ltd. C-1/119, Janak Puri, New Delhi - 110058 (INDIA) Mfd. by: G.D. Foods Mfg. (I) Pvt. Ltd. Plot No. SP-15&16. RIICO Industrial Area, Neemrana-301705, Dist. - Kotputli-Behror, Rajasthan (INDIA) Imported and Distributed by: Mangalm LLC California, USA Email: info@mangalm.com Phone: 925-302-6025 UPC: 8 904288 626322 Batch No.: 4F1101 Best Before: 10.06.26 NET QTY.: 16.75 oz (475g)
Unapproved color (carmoisine).
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
FDA DevicesBrand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
FDA DevicesProduct Name: Allura Xper FD10C; Model number: 722001;
Product Name: Allura Xper FD10C; Model number: 722001;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
FDA DevicesCentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
FDA DevicesMAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
FDA FoodTroemner Family Farm Pfeffernusse Cookies, 6oz and 12oz bags
Troemner Family Farm Pfeffernusse Cookies, 6oz and 12oz bags
undeclared soy, wheat, milk
FDA DevicesBoston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
FDA Devicesda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
FDA Food1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6
1972 Banana Pudding Ice Cream, 3 GAL, UPC 0 75196 00556 6
Undeclared soy lecithin
FDA DrugsNYQUIL COLD & FLU -32CT/2PK
NYQUIL COLD & FLU -32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesThe product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Potential for microbial contamination.
FDA DevicesFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
FDA DevicesBrand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.