Safety Recalls
RSS ↗15,379 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 14,301–14,350 of 15,379
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class II
Drug Recall · December 28, 2023
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Choice, Distributed by C.D.M.A. Inc., 43157 W 9 Mile Rd, Novi, MI 48375, NDC# 6386CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Class II
Drug Recall · December 28, 2023
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East LancasCGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SEThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
- Class II
Drug Recall · December 28, 2023
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant, 1 fl oz (30 mL) bottle, Distributed by C.D.M.A, Inc. 43157 W 9 Mile Rd. Novi, MCGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class II
Drug Recall · December 28, 2023
Fresenius Medical Care Holdings, Inc.
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.Lack of Sterility Assurance
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777TCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class II
Medical Device Recall · December 28, 2023
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syrinThe saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
- Class I
Drug Recall · December 28, 2023
Denver Solutions, LLC DBA Leiters Health
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777TCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class II
Drug Recall · December 28, 2023
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hours, 1 fl. oz. bottle, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd., Novi, MICGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SEThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SEThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
- Class II
Medical Device Recall · December 28, 2023
Bubble Sensor (REF: 70105.5720)The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
- Class II
Medical Device Recall · December 28, 2023
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- Class I
Medical Device Recall · December 28, 2023
Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SEThe listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
- Class I
Medical Device Recall · December 27, 2023
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product CodIFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
- Class II
Medical Device Recall · December 27, 2023
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
- Class II
Medical Device Recall · December 27, 2023
Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/ARetroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
- Class I
Drug Recall · December 26, 2023
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059Microbial Contamination of Non-Sterile Products
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class I
Drug Recall · December 26, 2023
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 0705Microbial Contamination of Non-Sterile Products
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class III
Drug Recall · December 26, 2023
Amerisource Health Services LLC
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual DoseSuperpotent drug: Assay results were slightly above specification at the time zero point.
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TRGE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class II
Drug Recall · December 26, 2023
Amneal Pharmaceuticals of New York, LLC
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, BridgewateFailed dissolution specifications
- Class II
Medical Device Recall · December 26, 2023
Senographe PristinaX-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
- Class II
Medical Device Recall · December 26, 2023
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
- Class I
Medical Device Recall · December 26, 2023
Wipro GE Healthcare Private Ltd.
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.
- Class I
Medical Device Recall · December 22, 2023
Baxter Exactamix Pro 2400, REF EXM24DYAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
- Class II
Medical Device Recall · December 22, 2023
Musculoskeletal Transplant Foundation, Inc.
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Class I
Food Recall · December 22, 2023
World Variety Produce Inc dba Melissa's
Melissa's Hot Kimchi Pickled Napa Cabbage NET WT. 14 oz (397g) Ingredients: Napa Cabbage, Radish, Water, Garlic, Red Pepper, Organic Sugar Cane, Sea Salt, Calcium Lactate, Ginger, Onion, Sorbitol, aUndeclared allergen; fish.
- Class II
Medical Device Recall · December 22, 2023
ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
- Class II
Medical Device Recall · December 22, 2023
Musculoskeletal Transplant Foundation, Inc.
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Class II
Medical Device Recall · December 22, 2023
GE HEALTHCARE AUSTRIA GMBH & CO
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysisGE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.
- Class I
Medical Device Recall · December 22, 2023
Baxter Exactamix Pro 1200, REF EXM12DYAn error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
- Class II
Medical Device Recall · December 22, 2023
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
- Class III
Food Recall · December 22, 2023
Nestle Product Technology Center - Nestle Health Science
Solgar, Triple Strength, Shellfish -Free, Glucosamine Chondroitin MSM, 120 Tablets per bottle. Glass Bottle, 12 per Case, Store at room temperature . Product Number -1319Nestle Health Science has initiated a recall of Solgar Glucosamine Chondroitin, 120 Tablets, in Glass bottle, 12 bottles per case because of error during packaging in which a A Megasorb B-Complex product was filled into bottles labeled as Glucosamine_Chondroitin MSM.
- Class II
Medical Device Recall · December 22, 2023
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplastyFailed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
- Class I
Medical Device Recall · December 22, 2023
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEOSterility assurance for saline included in surgical kits cannot be guaranteed.
- Class I
Medical Device Recall · December 22, 2023
Windstone Medical Packaging, Inc.
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEOSterility assurance for saline included in surgical kits cannot be guaranteed.