États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
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 DrugsTUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA FoodHerbsForever- Hingwastika Churna ; Ayruvedic Herbal Supplement; 90 VEGE Capsules; 100 GMS UPC: 8 07814 00622 4
HerbsForever- Hingwastika Churna ; Ayruvedic Herbal Supplement; 90 VEGE Capsules; 100 GMS UPC: 8 07814 00622 4
Potential undeclared allergen ingredient (Wheat)
FDA DevicesMedicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA DevicesMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
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 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 DrugsMOTRIN 2'S DISP.- 50CT
MOTRIN 2'S DISP.- 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsPersonal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DevicesAllura Xper FD20; Model Number: 722006;
Allura Xper FD20; Model Number: 722006;
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 DrugsNYQUIL COLD & FLU -32CT/2PK
NYQUIL COLD & FLU -32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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 DevicesFreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 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 DevicesAbre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
FDA DrugsHalls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsLevothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
FDA DevicesPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
FDA DrugsPEPCID COMPLETE - 25CT
PEPCID COMPLETE - 25CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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 DevicesMAXXUS, System, Tomography, Computed, Emission
MAXXUS, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
FDA DevicesAllura Xper FD10; Model Number: 722026;
Allura Xper FD10; Model Number: 722026;
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 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 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 medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
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 DevicesMedline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
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.