Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 13,951–14,000 of 15,379
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class II
Medical Device Recall · January 23, 2024
MEDLINE INDUSTRIES, LP - Northfield
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.Product failed sterility testing.
- Class II
Drug Recall · January 23, 2024
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland.Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Safe Lock Catheter Ext. 12 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Medical Device Recall · January 23, 2024
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 inThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
- Class I
Food Recall · January 23, 2024
Golden Owl Dried Mango 7 oz (200g) UPC 816710-024461. Packaged in clear non-flex plastic jars. 24 jars per case.Undeclared sulfites
- Class I
- Class II
Medical Device Recall · January 22, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item NumberMislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure aPotential for catheter disconnection from the patient line stopcock connectors.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce inPotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Drug Recall · January 22, 2024
IntegraDose Compounding Services LLC
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. OffSub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
- Class II
Medical Device Recall · January 22, 2024
Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracrPotential for catheter disconnection from the patient line stopcock connectors.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce inPotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Medical Device Recall · January 22, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administratioKits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- Class I
Medical Device Recall · January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressurePotential for catheter disconnection from the patient line stopcock connectors.
- Class II
Medical Device Recall · January 22, 2024
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOWInvacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
- Class II
Medical Device Recall · January 22, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epiKits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 22, 2024
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HPotential interference with the anti-fall system.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT7600 Integrated SystemPotential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 22, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
- Class II
Medical Device Recall · January 19, 2024
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Food Recall · January 19, 2024
Fortune cookies, individually wrapped in a 6lb case, 190 pcs / caseUndeclared allergens (soy)
- Class II
Medical Device Recall · January 19, 2024
Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holesDevices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE¿ VIABIL¿ Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
- Class II
Food Recall · January 19, 2024
Al Amir Fresh Foods Tzatziki Cucumber Yogurt, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 8 55134 12351 3. The recalled product laLabel declares Cream & Yogurt but does not declare milk.
- Class II
Drug Recall · January 19, 2024
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in product
- Class II
Drug Recall · January 19, 2024
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in product
- Class II
Drug Recall · January 19, 2024
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in product
- Class III
Medical Device Recall · January 19, 2024
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class II
Food Recall · January 19, 2024
Bulk case of Fortune cookies, labeled as 6 lb (1.3 lb per bag/ 4 bags per case)Undeclared allergens (wheat and soy)
- Class II
- Class I
Food Recall · January 19, 2024
Al Amir Fresh Foods Baba Ghannooj Grilled Eggplant, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12342 1. The recalled produHummus product label declares Tahini but does not declare sesame.
- Class III
Medical Device Recall · January 19, 2024
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class III
Medical Device Recall · January 19, 2024
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class I
Food Recall · January 19, 2024
Al Amir Fresh Foods Harissa Spicy Hummus With a Kick, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12352 0. The recalled proHummus product label declares Tahini but does not declare sesame.
- Class II
Medical Device Recall · January 19, 2024
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
- Class II
Medical Device Recall · January 19, 2024
Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Drug Recall · January 19, 2024
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 2CGMP Deviations: Potential Glass and Silicone particulates in product
- Class II
Medical Device Recall · January 19, 2024
Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class III
Medical Device Recall · January 19, 2024
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliancesCustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- Class II
Drug Recall · January 19, 2024
Omeza Skin Protectant, Skin Protectant Gel 10*2mL VialsCGMP Deviations
- Class II
Medical Device Recall · January 19, 2024
INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
- Class II
Medical Device Recall · January 19, 2024
Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.