États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesOlympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA DevicesFlexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
Probes may rupture/burst during activation
FDA DevicesOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
FDA DevicesHLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
FDA Food14" Margarita Thin Crust Pizza; 8 units per case. Keep Frozen UPC code: 1713940060
14" Margarita Thin Crust Pizza; 8 units per case. Keep Frozen UPC code: 1713940060
potential foreign object (metal pieces) in ingredient (Tomatoes)
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 Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
FDA FoodKing Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Spinach Hummus 10 oz. UPC 025726 311087
King Harvest brand Spinach Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Spinach Hummus 10 oz. UPC 025726 311087
Foreign material (aluminum pieces).
FDA FoodSlow Roasted Diced Tomatoes (SKU 821, UPC 00823338008216). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.
Slow Roasted Diced Tomatoes (SKU 821, UPC 00823338008216). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.
Product may contain foreign material (metal fragments).
FDA DevicesPhilips S4-1 Ultrasound Transducer
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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 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 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 FoodKing Harvest brand Balsamic Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Balsamic Hummus 10 oz. UPC 025726 310097
King Harvest brand Balsamic Hummus. Product is packed in 10oz plastic tubs with a clear film seal and a lid. Keep Refrigerated - Handcrafted in Portland OR kingharvesthummus.com. Balsamic Hummus 10 oz. UPC 025726 310097
Foreign material (aluminum pieces).
FDA FoodTops GOLD Lime Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611397 INGREDIENTS:***Mustard Oil***
Tops GOLD Lime Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611397 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
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
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.
FDA FoodTops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:***Mustard Oil*** Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950 INGREDIENTS:***Mustard Oil***
Tops GOLD Mixed Pickle NET QTY.: 31.74oz PRODUCT OF INDIA UPC: 8904288611380 INGREDIENTS:***Mustard Oil*** Tops GOLD Mixed Pickle NET QTY.: 158.73oz PRODUCT OF INDIA UPC: 8904288612950 INGREDIENTS:***Mustard Oil***
Potential adulteration with erucic acid from mustard oil ingredient.
FDA FoodChilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608-T20
Chilli Spanish Peanuts, First Street brand, 11oz clear plastic container. UPC: None Item Code: 2608-T20
Foreign object (glass) found inside sealed container of finished product.
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.
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 FoodKing Harvest brand Jalapeno 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. Jalapeno Hummus 10 oz. UPC 025726 310042 Jalapeno Hummus 17 oz. UPC 025726 310059
King Harvest brand Jalapeno 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. Jalapeno Hummus 10 oz. UPC 025726 310042 Jalapeno Hummus 17 oz. UPC 025726 310059
Foreign material (aluminum pieces).
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.