Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesPilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA FoodTops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:***Mustard Oil***
Tops GOLD Stuffed Red Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611953 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
FDA FoodPepsin 1:3000 Powder, 50 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Pepsin 1:3000 Powder, 50 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Potential Salmonella contamination.
FDA FoodItem 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Peppers Prepared with Sweet Soy Sauce Infused Rice. Net wt. 17oz. Retail box UPC 010878810915. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/17oz. boxes per case. Case UPC 10010878810912. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Vegetable - A Chinese Style Fried Rice with Edamame, Carrots, Fire Roasted Corn & Red Bell Peppers Prepared with Sweet Soy Sauce Infused Rice. Net wt. 17oz. Retail box UPC 010878810915. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 6/17oz. boxes per case. Case UPC 10010878810912. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
FDA FoodKing Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Roasted Red Pepper Hummus 10 oz. UPC 025726 311278 Roasted Red Pepper Hummus 17 oz. UPC 025726 311261
King Harvest brand Roasted Red Pepper Hummus. Product is packed in 10 and 17 oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Roasted Red Pepper Hummus 10 oz. UPC 025726 311278 Roasted Red Pepper Hummus 17 oz. UPC 025726 311261
Foreign material (aluminum pieces).
FDA FoodChilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item code: 2608-25
Chilli Spanish Peanuts, Treasured Harvest brand, 25lb clear plastic bag container. UPC:none Item code: 2608-25
Foreign object (glass) found inside sealed container of finished product.
FDA FoodLucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package is a plastic cup with foil lid and clear plastic lid. UPC 0 21130 07662 8. Distributed by Lucerne Foods, Inc PO Box 99, Pleasanton, CA. Product is distributed in a 6-pack case that consists of a flat cardboard tray and clear plastic film. There are no graphics on the distribution unit. The cases are broken down and product is merchandised as a single 24 oz.
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz. Perishable and keep refrigerated. Consumer package is a plastic cup with foil lid and clear plastic lid. UPC 0 21130 07662 8. Distributed by Lucerne Foods, Inc PO Box 99, Pleasanton, CA. Product is distributed in a 6-pack case that consists of a flat cardboard tray and clear plastic film. There are no graphics on the distribution unit. The cases are broken down and product is merchandised as a single 24 oz.
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.
FDA FoodTops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:***Mustard Oil***
Tops GOLD Green Chilli Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288612837 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
FDA FoodFavorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.
Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.
Label does not specify type of tree nut contained in the product.
RappelConsoferme de la croix marand - fressure
ferme de la croix marand - fressure
perte de maitrise du process de sterilisation
FDA DrugsCUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lack of Assurance of Sterility
FDA DevicesOlympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA DevicesPhilips OMNI II TEE Ultrasound Transducer
Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA DevicesPhilips X3-1 Ultrasound Transducer
Philips X3-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA FoodDoraditas de Azucar UPC 5901234123457
Doraditas de Azucar UPC 5901234123457
Gorditas and Doraditas are missing the following allergens in product label: Wheat and Soy
FDA DevicesEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
FDA DevicesPhilips L17-5 Ultrasound Transducer
Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA DevicesBD Alaris" System with Guardrails" Suite MX with Point of Care Unit
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
FDA DevicesCustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
FDA FoodKing Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Sundried Tomato Hummus 10 oz. UPC 025726 311186.
King Harvest brand Sundried Tomato Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Sundried Tomato Hummus 10 oz. UPC 025726 311186.
Foreign material (aluminum pieces).
FDA DevicesTandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
FDA DevicesPhilips S5-2 Ultrasound Transducer
Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
NHTSAVolkswagen Group of America, Inc. - Sunroof Malfunction/FMVSS 118
Volkswagen Group of America, Inc. - Sunroof Malfunction/FMVSS 118
Closing the sunroof without the ability to see it can increase the risk of injury to occupants.
FDA DevicesImactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.