Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,151–10,200 of 15,364
- Class I
Drug Recall · September 17, 2024
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Class II
Medical Device Recall · September 17, 2024
Canon Medical System, USA, INC.
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
- Class II
Food Recall · September 16, 2024
Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep FrozenUndeclared Yellow 5 & Yellow 6
- Class II
Food Recall · September 16, 2024
Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep FrozenUndeclared Yellow 5 & Yellow 6
- Class II
Drug Recall · September 16, 2024
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Class II
Food Recall · September 16, 2024
Premium Pistachio Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep FrozenUndeclared Yellow 5 & Yellow 6
- Class I
Medical Device Recall · September 16, 2024
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapyAs a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
- Class II
Drug Recall · September 16, 2024
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 3002303Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Class II
Medical Device Recall · September 16, 2024
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
- Class II
Food Recall · September 16, 2024
Premium Grapenut Special, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep FrozenUndeclared Yellow 5 & Yellow 6
- Class II
Medical Device Recall · September 16, 2024
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come withCook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
- Class II
Food Recall · September 16, 2024
Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep FrozenUndeclared Yellow 5 & Yellow 6
- Class II
Medical Device Recall · September 16, 2024
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deploPossible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
- Class II
Medical Device Recall · September 16, 2024
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
- Class II
Food Recall · September 14, 2024
Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. Macrina Bakery - Kent, WA. Ingredients: CANE SUGAR, GREEK YOGUUndeclared walnut and wheat. Mini Squash Harvest Loaf (UPC 8 55324 00505 3) was mis-labeled as Mini Raspberry Lemon Coffee Cake (UPC 8 57297 00745 4) and therefore wheat flour and walnuts are not declared on label.
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lbs 8oz.Undeclared sesame
- Class I
Food Recall · September 13, 2024
Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bagsUndeclared allergens; milk
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.Undeclared sesame
- Class I
Food Recall · September 13, 2024
S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016Undeclared Allergen, milk - a mix-up between the product description and the ingredient list. Milk Chocolate was listed in the product description but was missing from the ingredient list.
- Class I
Medical Device Recall · September 13, 2024
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64zThere is a defect in the air-in-line software algorithm.
- Class II
Medical Device Recall · September 13, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component:Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.Undeclared sesame
- Class I
Food Recall · September 13, 2024
Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. Net. Wt. 9lbs. 6oz.Undeclared sesame
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.Undeclared sesame
- Class II
Medical Device Recall · September 13, 2024
Olympus Corporation of the Americas
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse White Pullman Bread 1/2" Sliced 22 OUNCE. 12 unlabeled 22 OUNCE LOAVES per sale unit case, product code 9518. Net Wt. 16lb 8oz.Undeclared sesame
- Class III
Medical Device Recall · September 13, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
- Class I
Food Recall · September 13, 2024
Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.Undeclared sesame
- Class I
Food Recall · September 13, 2024
Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bagsUndeclared allergens; milk
- Class II
Medical Device Recall · September 13, 2024
Olympus Corporation of the Americas
EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscoMislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
- Class II
Medical Device Recall · September 13, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
- Class II
Medical Device Recall · September 12, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
- Unclassified
Consumer Product Recall · September 12, 2024
Costco Wholesale, of Issaquah, Washington
Stanley Jr. Kids Wheelbarrow and 7-piece Garden SetsThe painted long hoe and rake of the recalled garden set contain levels of lead that exceed the federal lead paint ban, posing a lead poisoning hazard to children. Lead is toxic if ingested by young children and can cause adverse health issues.
- Unclassified
Consumer Product Recall · September 12, 2024
Glen Dimplex Americas Ltd., of Vancouver, Washington
Cadet-branded Apex72 Electric HeatersThe fan can malfunction and fail to turn on causing the unit to overheat and ignite internally, posing a fire hazard.
- Unclassified
Consumer Product Recall · September 12, 2024
Worldwide Windows Inc., of China
MJKSARE High ChairsThe recalled high chairs violate the regulations for high chairs, as the leg openings on the high chair are too wide, posing an entrapment hazard to infants. Additionally, the high chairs pose a fall hazard because the tray can become disengaged from the product.
- Unclassified
Consumer Product Recall · September 12, 2024
Petzl America, Inc., of Salt Lake City, Utah
Petzl GYM, PANDION and PANJI climbing harnessesThe recalled harness can be put on backwards and the rope or carabiner can be attached to a non-weight-bearing leg loop elastic band, placing the user at risk of falling from height and sustaining serious injury, including paraplegia or death.
- Class III
Food Recall · September 12, 2024
Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,090426,090526,090626.Product tested positive for coliforms.
- Class III
Medical Device Recall · September 12, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controllinIncorrect GTIN number.
- Class II
Medical Device Recall · September 12, 2024
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality aSynapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy
- Class II
Medical Device Recall · September 12, 2024
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
- Class I
Medical Device Recall · September 12, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CPThe Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- Unclassified
Consumer Product Recall · September 12, 2024
Bestway (Hong Kong) International Ltd., of China
AirJet and HydroJet Spa PumpsThe recalled AirJet and HydroJet spa pumps can overheat causing the plastic housing to ignite, posing a fire hazard.
- Unclassified
Consumer Product Recall · September 12, 2024
GuangZhouShiYiYangKangTiSheBeiYouXianGongSi, dba GOETAS, of China
GOETAS Pool Drain CoversThe recalled drain covers do not conform to the entrapment protection regulations of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing an entrapment hazard to swimmers and bathers.
- Unclassified
Consumer Product Recall · September 12, 2024
Intellio Toys, of Houston, Texas
Bright Builder Fort Kits with FlashlightsThe flashlight on the recalled kits violates the mandatory federal battery-operated toy regulation because the flashlights contain button cell batteries in a compartment that can be easily opened without requiring the use of a common household tool. When button cell batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death, posing an ingestion hazard.
- Class II
Food Recall · September 11, 2024
Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.Soybean Paste is declared but Wheat and Sesame Seeds are not declared.
- Class I
Food Recall · September 11, 2024
Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, Salt, Garlic, Soy Sauce, Chili Powder.Undeclared Fish (Anchovy).
- Class II
Medical Device Recall · September 11, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20Potential for error and inability to interrogate pump due to data corruption in the pump memory.
- Class III
Food Recall · September 11, 2024
Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, SaltSoy Sauce is declared but Wheat is not declared.
- Class II
Drug Recall · September 11, 2024
Mckesson Medical-Surgical Inc. Corporate Office
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06Temperature abuse: Products exposed to improper temperature above drug label specifications.
- Class I
Food Recall · September 11, 2024
Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable.Mayonnaise is declared but Soybean Oil and Egg are not declared.