Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA Food#007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094
#007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094
Products may be potentially contaminated with Salmonella.
FDA DevicesBD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
FDA DevicesBD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
FDA DevicesIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
FDA DevicesBD Pyxis MedStation ES REF: 323 Medication cabinet
BD Pyxis MedStation ES REF: 323 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA DevicesARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
FDA DrugsXyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
FDA DevicesBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
FDA DevicesCovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
FDA DevicesBD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA DevicesPediatric care bed; Product Designation: KayserBett IDA;
Pediatric care bed; Product Designation: KayserBett IDA;
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).
FDA DevicesBD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405671.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
FDA DevicesBrand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
FDA DevicesCovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Temperature probe devices lack FDA clearance.
FDA Food#009530 Ranch Seasoning, Net Wt: 50 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094.
#009530 Ranch Seasoning, Net Wt: 50 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094.
Products may be potentially contaminated with Salmonella.
FDA FoodAlfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC 0039954921963
Alfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC 0039954921963
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
FDA Fooda2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East Circle, Suite 300 Boulder CO 80301.
a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East Circle, Suite 300 Boulder CO 80301.
Possible contamination with Cereulide toxin.
FDA DevicesArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
FDA FoodMarket of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell container. Label has UPC 0 210126 01099 3. Market Central Kitchen 1150 Owen Loop S. Eugene, OR 97402 The Za'atar spice, which contains Sesame Seeds, is mixed with chickpeas and packaged into a 2-oz plastic cup. This 2-oz. cup with chickpeas is then assembled into the finished product: a 9.5oz flexible clear plastic clamshell container of Vegan Kale Caesar Salad.
Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell container. Label has UPC 0 210126 01099 3. Market Central Kitchen 1150 Owen Loop S. Eugene, OR 97402 The Za'atar spice, which contains Sesame Seeds, is mixed with chickpeas and packaged into a 2-oz plastic cup. This 2-oz. cup with chickpeas is then assembled into the finished product: a 9.5oz flexible clear plastic clamshell container of Vegan Kale Caesar Salad.
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.
FDA FoodUPC 21788400000 Ready Meals SANDWICH TUNA SALAD CROISSANT SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 21788400000 Ready Meals SANDWICH TUNA SALAD CROISSANT SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare TUNA
FDA FoodUPC 21299900000 LOX AVOCADO TOAST FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 21299900000 LOX AVOCADO TOAST FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
FDA DevicesBD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
FDA FoodUPC 21330300000 Ready Meals BAKED POLLOCK 4CT SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 21330300000 Ready Meals BAKED POLLOCK 4CT SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Pollock
FDA FoodUPC 25047100000 ANDRONICO'S SWEET START CATERING TRAY LARGE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
UPC 25047100000 ANDRONICO'S SWEET START CATERING TRAY LARGE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Walnut