États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesMeijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
FDA FoodYO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
YO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
Product contains undeclared cyclamates.
FDA DrugsVista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA FoodGerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.
FDA DevicesAdapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
FDA FoodValley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Water was bottled under insanitary conditions.
FDA DevicesMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DrugsAdbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA,
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
FDA DevicesCampy CVA Medium 100/PK, R01272
Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
FDA FoodFish Ball, Frozen, 20 pieces per pack, 400g Wt. UPC# 810093891325
Fish Ball, Frozen, 20 pieces per pack, 400g Wt. UPC# 810093891325
Undeclared allergen ingredient (Wheat and Sesame)
FDA DevicesMedline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
FDA DevicesBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Software anomaly in the patient positioning system may result in positional discrepancy.
FDA DevicesBrand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Software anomaly in the patient positioning system may result in positional discrepancy.
FDA DrugsAmantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
FDA DrugsBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DevicesOlympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
NHTSAVolkswagen Group of America, Inc. - Lane Departure Warning Deactivated
Volkswagen Group of America, Inc. - Lane Departure Warning Deactivated
The driver may be unaware that the lane departure warning system is deactivated and rely on a system that is not functional, increasing the risk of a crash.
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA FoodWellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
Contaminated with Listeria monocytogenes
NHTSAFord Motor Company - Passenger-Side Headlight Malfunction/FMVSS 108
Ford Motor Company - Passenger-Side Headlight Malfunction/FMVSS 108
A headlight that turns incorrectly can result in increased glare to other road users, increasing the risk of a crash.
USDA FSISAjinomoto Foods North America, Inc. Expands Recall for Chicken and Pork Fried Rice, Ramen, and Shu Mai Products Due to Possible Foreign Matter Contamination
Ajinomoto Foods North America, Inc. Expands Recall for Chicken and Pork Fried Rice, Ramen, and Shu Mai Products Due to Possible Foreign Matter Contamination
Product Contamination
NHTSAFord Motor Company - Loss of Drive Power from EGR Valve Failure
Ford Motor Company - Loss of Drive Power from EGR Valve Failure
An unexpected loss of drive power increases the risk of a crash.
NHTSAFord Motor Company - Driver's Seat May Move Unexpectedly
Ford Motor Company - Driver's Seat May Move Unexpectedly
Unexpected movement of the driver’s seat may affect the driver’s ability to control the vehicle, increasing the risk of a crash.