Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA FoodBulk packaged Colustrum Powder. packaged with generic product label.
Bulk packaged Colustrum Powder. packaged with generic product label.
Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.
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 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 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 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 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 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 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 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 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 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 DevicesOlecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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 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 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 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.
Health CanadaFromagerie Marie Kadé and Les Aliments Karnie brand Halloom and Nabulsi Semi-Firm Unripened Cheese recalled due to generic E. coli
Fromagerie Marie Kadé and Les Aliments Karnie brand Halloom and Nabulsi Semi-Firm Unripened Cheese recalled due to generic E. coli
E. Coli - non-pathogenic
RappelConsodonna indiana professional - gluhen hair cuticl restore mask step1, 1l
donna indiana professional - gluhen hair cuticl restore mask step1, 1l
présence de substance interdites (méthylchloroisothiazolinone et de méthylisothiazolinone non autorisées dans les produits non rincés et du¤formaldéhyde) et d'une substance non étiquetée dans la liste d'ingrédients (acide glyoxylique).¤
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.
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 FoodSlow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). 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 900, UPC 00823338009008). 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 FoodPepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Pepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Potential Salmonella contamination.
FDA DrugsOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
FDA DevicesDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)