Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,951–10,000 of 15,364
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Unclassified
Consumer Product Recall · September 26, 2024
Deere & Company, of Moline, Illinois
John Deere 1023E, 1025R, and 2025R Compact Utility TractorsThe front bell crank in the brake linkage can fail causing the tractor to lose braking, resulting in a crash hazard.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Class III
Food Recall · September 26, 2024
Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 PackFD&C Red No 3 was not declared as an ingredient.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Class II
Medical Device Recall · September 26, 2024
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694Out of specification endotoxin levels.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Class II
Food Recall · September 26, 2024
Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) BroomfPotential for premature product spoilage during shelf life.
- Class II
Medical Device Recall · September 26, 2024
King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Unclassified
Consumer Product Recall · September 26, 2024
Liberty Hardware Manufacturing Corp., of Winston-Salem, North Carolina
Multi-Grip Tub Safety BarsThe plastic sticker grip pads can become dislodged after installation on tubs with tapered side walls, making the recalled Multi-Grip Tub Safety Bars unstable during use, posing a fall hazard.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58CGMP violations
- Class II
Medical Device Recall · September 25, 2024
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRKits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59cGMP violations
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58cGMP violations
- Class III
Drug Recall · September 25, 2024
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58cGMP violations
- Class III
Drug Recall · September 25, 2024
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Class II
Drug Recall · September 25, 2024
Fresenius Kabi Compounding, LLC
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56cGMP violations
- Class II
Medical Device Recall · September 25, 2024
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358HComplaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- Class I
Medical Device Recall · September 25, 2024
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
- Class I
Medical Device Recall · September 25, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell StereotactiElekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, SterileRetrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
- Class II
Medical Device Recall · September 24, 2024
medex Arterial Kit 1/EA, Product Code REF MX7827Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
Olympus Corporation of the Americas
Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images fDoes not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
- Class II
Medical Device Recall · September 24, 2024
medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SCDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFTDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
West Pharmaceutical Services AZ, Inc.
Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mmDue to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Disposable Transducer 1/EA, Product Code REF MX950Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Food Recall · September 24, 2024
Grabeez The Big Cheese SNACK MIX Net Wt. 3.25 oz (92g) Ingredients: Peanuts***Cheese Pretzel Gems***Vegetable Shortening***Snackin' Mix***Cheez-It Crackers***Cheese Wicks***Contains Milk, Peanuts, SoyUndeclared Almonds & Cashews. The firm was notified by their customers that the product contains a trail mix instead of the cheese mix. The trail mix contains almonds and cashews that are not listed in the ingredient statement.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar Single ICP Set 1/EA, Product Code REF MX20897Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
- Class II
Medical Device Recall · September 24, 2024
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502TDue to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.