Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 11,151–11,200 of 15,364
- Unclassified
Consumer Product Recall · July 11, 2024
Claire's and Icing Stores, of Hoffman Estates, Illinois
Halloween Witch HatsThe hats violate federal flammability requirements, posing a risk of burn injuries to consumers.
- Unclassified
Consumer Product Recall · July 11, 2024
Tong Tai Clothing Co. Ltd., dba Lovely Angel, of China
Lovely Angel Children's Lace NightgownsThe children's nightgowns violate the federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- Unclassified
Consumer Product Recall · July 11, 2024
Children's Button-up Short-Sleeve/Shorts Two-Piece Pajama SetsThe recalled children's pajama sets violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- Unclassified
Consumer Product Recall · July 11, 2024
Oneida International Ltd., dba TonGass, of China
TonGass pool drain coversThe recalled drain covers do not conform to the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing an entrapment hazard to swimmers and bathers.
- Class II
Medical Device Recall · July 10, 2024
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
- Class II
Medical Device Recall · July 10, 2024
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiationTemporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
- Class II
Medical Device Recall · July 10, 2024
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter InstructionDue to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
- Class II
Medical Device Recall · July 10, 2024
Ortho-Clinical Diagnostics, Inc.
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide fThe reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.
- Class II
Food Recall · July 10, 2024
Signature Blue Swimming Crab Claw and Lump 1lb can Tin Can, Lot # 78821 Expiration June 09th 2026, Lot # 788454 Expiration June 09th 2026Product was recalled due to the temperature being over 40 degrees and not on ice July 1st, 2024
- Class I
Drug Recall · July 10, 2024
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977,Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
- Class II
Medical Device Recall · July 10, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrumentBeckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.
- Class II
Medical Device Recall · July 9, 2024
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet systemDue to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- Class II
Medical Device Recall · July 9, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
- Class I
Medical Device Recall · July 9, 2024
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
- Class II
Medical Device Recall · July 9, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Class II
Medical Device Recall · July 9, 2024
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet systemDue to software issue, there is a potential when a restock label is printed for a medication stored in a non-CUBIE location, that the incorrect bin for the medication is printed on the label.
- Class I
Medical Device Recall · July 9, 2024
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
- Class II
Medical Device Recall · July 9, 2024
Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Class III
Food Recall · July 9, 2024
Fox's u-bet Sugar-Free Chocolate Flavored Syrup, 18oz, UPC 070216246004, 12 retail units per wholesale caseCustomer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.
- Class II
Food Recall · July 9, 2024
All Natural KALO Chocolate Cake Gluten Free, UPC 8 53407 00418 4, Distributed by: Kalo Foods, LLC Stokesdale, NC 27357Undeclared Soy. Carrot Cake slices were inadvertently placed into some Chocolate Cake slice containers. The Chocolate Cake ingredient statement does not list the allergen soy which is in the Carrot Cake.
- Class II
Medical Device Recall · July 9, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
- Class II
Medical Device Recall · July 9, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Class II
Drug Recall · July 9, 2024
SUN PHARMACEUTICAL INDUSTRIES INC
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, DehraduFailed Dissolution Specifications
- Class II
Medical Device Recall · July 9, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
- Class II
Medical Device Recall · July 9, 2024
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care.
- Class III
Food Recall · July 9, 2024
Fox's u-bet Vanilla Flavored Syrup, 20oz, UPC 070216241016, 12 retail units per wholesale caseCustomer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.
- Class II
Medical Device Recall · July 9, 2024
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyIFU update to address device's battery handling information.
- Class II
Medical Device Recall · July 9, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
- Class II
Medical Device Recall · July 9, 2024
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and sSpecific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
- Class II
Medical Device Recall · July 8, 2024
GM60A. Digital Diagnostic Mobile X-Ray System.Potential for the anti-fall system of the device arm to fail.
- Class II
Medical Device Recall · July 8, 2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versionsSafety Parameters Verification Mechanisms can be deactivated in clinical runtime
- Unclassified
Vehicle Recall · July 8, 2024
2024 HYUNDAI SONATAFlashing brake lights may cause confusion for other drivers on the road, increasing the risk of a crash.
- Unclassified
Vehicle Recall · July 8, 2024
2024 GENESIS GV60, 2025 GENESIS GV80, 2025 GENESIS GV60A rearview camera image that does not display decreases the driver's visibility, increasing the risk of a crash.
- Class I
Drug Recall · July 8, 2024
Hikma Pharmaceuticals USA Inc.
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma PharmaceutLabeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
- Class I
Food Recall · July 8, 2024
Shelled Walnuts 1lb package in plastic flexible packaging. 24 packages per caseShelled walnuts tested positive for Listeria
- Unclassified
Vehicle Recall · July 6, 2024
2023 NOVA BUS LFSAn unexpected engine shutdown increases the risk of a crash. An overheated ground connection can increase the risk of a fire.
- Unclassified
Vehicle Recall · July 6, 2024
2024 KIA SPORTAGEA loss of power steering assist can increase the risk of a crash.
- Class III
Medical Device Recall · July 5, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone iInvalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
- Class II
Food Recall · July 5, 2024
Lunds & Byerlys pesto salmon and lemon rice. UPC 18169-66396. Net Wt. 12 oz. (340.2g). Keep Refrigerated.Peach tilapia and edamame rice steamer may be mis-labeled as pesto salmon and lemon rice: Undeclared Fish (Tilapia), and Soybeans
- Unclassified
Vehicle Recall · July 5, 2024
2023 WINNEBAGO VIEW, 2023 WINNEBAGO NAVION, 2023 WINNEBAGO REVEL, 2024 WINNEBAGO VITA, 2024 WINNEBAGO VIEW, 2024 WINNEBAGO REVEL, 2024 WINNEBAGO EKKO, 2025 WINNEBAGO VIEW, 2025 WINNEBAGO EKKODamaged wires can prevent air bags from deploying in a crash, increasing the risk of injury.
- Class II
Medical Device Recall · July 5, 2024
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069Product was distributed past expiration date.
- Class II
Medical Device Recall · July 4, 2024
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM SystemDuring the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
- Class II
Medical Device Recall · July 3, 2024
Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as welIf the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
- Unclassified
Consumer Product Recall · July 3, 2024
American Honda Motor Co. Inc., of Torrance, California
Model Year 2023-2024 Off-Road MotorcyclesThe grip can detach from the handlebar, posing crash and injury hazards.
- Unclassified
Consumer Product Recall · July 3, 2024
ShenZhen Bai Si Te Clothing Limited Company, dba SWOMOG, of China
SWOMOG Children's Two-Piece Pajama SetsThe children's pajama sets violate the federal flammability standards for children's sleepwear, posing a burn hazard to children.
- Unclassified
Consumer Product Recall · July 3, 2024
Hatch Baby Inc., of Palo Alto, California
Power Adapters sold with Rest 1st Generation sound machinesThe plastic housing surrounding the AC power adapter supplied with some Rest 1st Generation sound machines can come off when removing the adapter from the power outlet, leaving the power prongs exposed and posing a shock hazard to consumers.
- Unclassified
Vehicle Recall · July 3, 2024
Honda (American Honda Motor Co.)
2023 HONDA RIDGELINE, 2023 HONDA PASSPORTA loss of steering control increases the risk of a crash.
- Class II
Drug Recall · July 3, 2024
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81Subpotent Drug: reduced efficacy for epinephrine
- Class I
Food Recall · July 3, 2024
The recalled product is mis-labeled as Ancient Grain + Vegetable Salad item #25247. Product is perishable, refrigerated, and packaged in clear dome clamshell plastic container. Net weight approximatUndeclared Almond and Soy. The Grain + Celery Salad with Apple Cider Vinaigrette item #47492 was inadvertently mis-labeled as Ancient Grain + Vegetable Salad item #25247. Almond and Soy were not declared on the label of Ancient Grain + Vegetable Salad item #25247.
- Class II
Medical Device Recall · July 3, 2024
Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizatiIf the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.