Safety Recalls

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15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 6,351–6,400 of 15,271

Medical Device Recall · May 28, 2025
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips X6-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 7
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips eL18-4 EMT Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Drug Recall · May 28, 2025
Apotex Corp.
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips S5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Drug Recall · May 28, 2025
Apotex Corp.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, F
Lack of Assurance of Sterility
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips XL14-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips L8-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Food Recall · May 28, 2025
Post Consumer Brands, LLC
Post Honey Bunches of Oats with Almonds. Sweetened Cereal with Oats and Honey. Net Wt 48 oz (3 lbs) 1.36kg. 2 Bags inside for freshness. UPC 8 84912-01428 3. Post Consumer Brands, LLC, Lakeville,
Foreign Material (metal)
Class II
Medical Device Recall · May 28, 2025
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devi
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II
Medical Device Recall · May 28, 2025
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devi
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips C9-5EC Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips 3D9-3v Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips L9-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Stryker GmbH
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips S7-3t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devi
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II
Drug Recall · May 28, 2025
Apotex Corp.
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Lack of Assurance of Sterility
Class II
Drug Recall · May 28, 2025
Pfizer Inc.
DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Fores
Discoloration; discolored solution from cracked vials
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips eL18-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Food Recall · May 28, 2025
Camerican International Inc
Casa Mamita, Churro Bites Filled with Chocolate Hazelnut Cream, 7.5 oz , Cardboard Box, 12 boxes per case, Keep Frozen Until Ready For Use
Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips C5-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips L12-3 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips V6-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Encore Medical, LP
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devi
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips S7-2 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips X7-2t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips X5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips S8-3t Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips C5-1 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips L12-4 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Medical Device Recall · May 28, 2025
Philips Ultrasound, Inc
Philips VL13-5 Transducer.
Ultrasound transducer devices were refurbished beyond their useful life.
Class II
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG21004 Brussels Sprouts, Roasted 2514111 FG21004 Brussels Sprouts, Roasted 2514311 Packaged 7- 2 lb polybags per cardboard case
Potential to be contaminated with Listeria monocytogenes
Class I
Medical Device Recall · May 27, 2025
Microbiologics Inc
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Class II
Medical Device Recall · May 27, 2025
Medtronic Navigation, Inc.-Boxborough
O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Class II
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG20004 Cucumber, Sliced packaged in poly bag, and cardboard case. 16 lbs per case
Potential to be contaminated with Listeria monocytogenes
Class I
Food Recall · May 27, 2025
Kilwin's Quality Confections, Inc.
Kilwin's Truffle Assortment 9.5oz UPC 0 004574 0 Kilwin's Truffle Assortment 8oz UPC 0 043109 5 Kilwin's Truffle Assortment 4.75oz UPC 0 044121 8
undeclared pecans
Class I
Food Recall · May 27, 2025
East Africa Boutique, LLC.
Super Cereal Plus fortified corn soya blend, Net Weight 1.5 kg, packaged in a plastic foil bag, packed 9 bags per case
Products held under insanitary conditions
Class II
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
Red cabbage, shredded packed in polybag and cardboard case. 14 lbs per case.
Potential to be contaminated with Listeria monocytogenes
Class I
Food Recall · May 27, 2025
Kilwin's Quality Confections, Inc.
Kilwin's Mocha Truffle bulk 2.5lbs Kilwin's Mocha Truffles 4.75oz UPC 0 043110 5
undeclared pecans
Class I
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG20007 Pepper, Red Bell Chop packaged in poly bag, and cardboard case. 17.5 lbs per case
Potential to be contaminated with Listeria monocytogenes
Class I
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG21002 Potato, Cooked Breakfast 2514111; 2514111B FG21002 Potato, Cooked Breakfast 2514311 Packaged 3- 5 lb polybags per cardboard case
Potential to be contaminated with Listeria monocytogenes
Class I
Drug Recall · May 27, 2025
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 136
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II
Drug Recall · May 27, 2025
Torrent Pharma Inc.
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG20044 Tomato, Grape CV 2514111 ; 2514111B FG20004 Tomato, Grape CV 2514211 Packaged 4- 2.5lb polybags per cardboard case
Potential to be contaminated with Listeria monocytogenes
Class I
Drug Recall · May 27, 2025
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Lack of Assurance of Sterility
Class II
Food Recall · May 27, 2025
East Africa Boutique, LLC.
Nootri Toto, Net Weight 1 kg, packaged in a cardboard box, packed 12 boxes per case
Products held under insanitary conditions
Class II
Food Recall · May 27, 2025
AND GO CONCEPTS DBA SALAD AND GO
FG20001 Onion, Red Diced packaged in poly bag and cardboard case. 18 lbs per case
Potential to be contaminated with Listeria monocytogenes
Class I
Food Recall · May 27, 2025
The Whole Herb Company, Inc.
Celery Seed Whole Organic, labeled, "CELERY SEED WHL OG; Net Wt: 56.25 Lbs"
Potential contamination with Salmonella.
Class I