Safety Recalls

15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 4,701–4,750 of 15,200

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  Fresenius Kabi USA, LLC

  Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

  Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

  Class II

• Food Recall · September 3, 2025

  New Spirit Naturals Inc.

  Super Muscle Support Powder; 300 grams/container UPC: NA

  undeclared allergen ingredient Milk.

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-0

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Food Recall · September 3, 2025

  New Spirit Naturals Inc.

  Ultra Whey Protein Powder; 1.4 lbs and 1.4 lbs. Chocolate flavor UPC: NA

  undeclared allergen ingredient Milk.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  Beckman Coulter Inc.

  SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.

  Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

  Class II

• Food Recall · September 3, 2025

  Zingerman's Coffee Company

  Zingerman's Ca$hew Cow Candy Bar net wt 2oz UPC 844397000157

  Undeclared peanut

  Class I

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Drug Recall · September 3, 2025

  Glenmark Pharmaceuticals Inc., USA

  Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark

  Failed Impurities/Degradation Specifications

  Class II

• Medical Device Recall · September 3, 2025

  Inpeco S.A.

  FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

  The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Food Recall · September 3, 2025

  New Spirit Naturals Inc.

  Meal In A Glass protein powder. 1.05 lbs and 4.5 lbs container. UPC: NA Vanilla, Chocolate and Strawberry flavor.

  undeclared allergen ingredient Milk.

  Class II

• Food Recall · September 3, 2025

  Endico Potatoes Inc

  Endico brand PEAS & CARROTS; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until

  Product may be contaminated with Listeria monocytogenes.

  Class I

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Drug Recall · September 3, 2025

  Zydus Pharmaceuticals (USA) Inc

  Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-0

  CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

  Class II

• Drug Recall · September 3, 2025

  SUN PHARMACEUTICAL INDUSTRIES INC

  Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1

  Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

  Class II

• Food Recall · September 3, 2025

  Zingerman's Coffee Company

  Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237

  Undeclared cashew

  Class I

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

  Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Medical Device Recall · September 3, 2025

  Inpeco S.A.

  FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

  The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

  Class II

• Medical Device Recall · September 3, 2025

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

  The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

  Class II

• Drug Recall · September 2, 2025

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (O

  Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Medical Device Recall · September 2, 2025

  Canon Medical System, USA, INC.

  This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures f

  It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.

  Class II

• Drug Recall · September 2, 2025

  AvKARE

  Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski,

  Failed Content Uniformity Specifications

  Class II

• Drug Recall · September 2, 2025

  The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

  Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapol

  Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

  Class II

• Medical Device Recall · September 2, 2025

  LeMaitre Vascular, Inc.

  Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (1

  The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

  Class II

• Medical Device Recall · September 2, 2025

  Berkeley Advanced Biomaterials, LLC

  Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities

  Due to incorrect product label (Incorrect product name identified on outer packaging).

  Class II