Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 11,851–11,900 of 15,364
- Class III
Drug Recall · May 28, 2024
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-0Defective Container
- Class II
Medical Device Recall · May 28, 2024
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG PulmonGrafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Class II
Medical Device Recall · May 27, 2024
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic pDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
- Class II
Medical Device Recall · May 27, 2024
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic pDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
- Class II
Medical Device Recall · May 27, 2024
Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proDuring positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
- Class II
Medical Device Recall · May 27, 2024
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
- Class I
Drug Recall · May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Class I
Food Recall · May 24, 2024
Farmalac 0-12 Low lactose powdered infant formula with iron 12.4 oz cansThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.
- Class I
Food Recall · May 24, 2024
Pop a Nosh Mixed Munch; Regular Flavor; 8oz plastic bag; Potato Chips, Popcorn, Pretzels; UPC 914669941Products contain undeclared wheat.
- Class II
Medical Device Recall · May 24, 2024
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
- Class I
Food Recall · May 24, 2024
Pop a Nosh Mixed Munch; Honey BBQ Flavor; 8oz plastic bag; Potato Chips, Popcorn, Pretzels; UPC 914669941Products contain undeclared wheat.
- Class II
Medical Device Recall · May 24, 2024
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
- Class I
Food Recall · May 24, 2024
Farmalac powdered infant formula with iron 12.4 oz cansThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.
- Class I
Food Recall · May 24, 2024
Crecelac Infant 0-12 powdered infant formula with iron 12.4 oz cansThe firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Cronobacter spp. detected by FDA sampling.
- Class I
Food Recall · May 23, 2024
Fresh Start Produce Sales, Inc.
Whole Cucumber, bulk cardboard boxes, 1 1/9 Bu, 60-72 ct cucumbers per box, 24ct box, Carton 36 ct box. Packaged in cardboard container box, color brown with Green and Red inked Accent colors. GrownDue to Salmonella in Cucumbers
- Class II
Drug Recall · May 23, 2024
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, MadeFailed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Class II
Medical Device Recall · May 23, 2024
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
- Class II
Drug Recall · May 23, 2024
Dr. Reddy's Laboratories, Inc.
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52Lack of Assurance of Sterility: Leaking vials
- Class II
Medical Device Recall · May 23, 2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
- Class II
Food Recall · May 23, 2024
Moore Family Farms and Creamery Cheddar Cheese Curds, 1 pound plastic bags, packaged with white tiesHigh coliform and generic E. coli count
- Class II
Medical Device Recall · May 23, 2024
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
- Unclassified
Consumer Product Recall · May 23, 2024
Dong Guan Shi Li Peng Zhi Dian Zi Shang Wu You Xian Gong Si, dba Sanure Storefront, of China
TOPINCN 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 · May 22, 2024
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support SystemDue to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
- Class II
Medical Device Recall · May 22, 2024
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.Potential for inaccurate fetal heart rate measurements when monitoring multiples.
- Class II
Medical Device Recall · May 22, 2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- Class II
Medical Device Recall · May 22, 2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MPDue to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
- Class II
Medical Device Recall · May 22, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 TibBlind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Class II
Medical Device Recall · May 22, 2024
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- Class II
Medical Device Recall · May 22, 2024
DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
- Class II
Drug Recall · May 22, 2024
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
- Class III
Drug Recall · May 22, 2024
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- Class II
Medical Device Recall · May 22, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
- Class II
Medical Device Recall · May 22, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
- Class II
Medical Device Recall · May 22, 2024
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- Class II
Medical Device Recall · May 22, 2024
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyTheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- Class II
Medical Device Recall · May 21, 2024
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC UnitsDue to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
- Class II
Medical Device Recall · May 21, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
- Class II
Medical Device Recall · May 21, 2024
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
- Class II
Food Recall · May 21, 2024
Advance Food International Inc.
Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200g); packaged in clear plastic zip-top bagsProduct contains elevated levels of lead (2,030 ppb)
- Class II
Drug Recall · May 20, 2024
Contract Pharmacal Corporation
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730Discoloration: Brownish tablets
- Class II
Drug Recall · May 20, 2024
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Class II
Drug Recall · May 20, 2024
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc.,Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Class II
Drug Recall · May 20, 2024
Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intramuscular or Intravenous Use, Rx Only, Distributed by Hospira, Inc., LLack of Assurance of Sterility-The potential for incomplete crimp seals.
- Class II
Medical Device Recall · May 20, 2024
Pink Luminous Breast, Breast transilluminatorFirm is marketing and distributing the Pink Luminous Breast device without premarket approval
- Class I
Food Recall · May 17, 2024
Irvington Seafood, Inc. dba ISF, Inc.
Irvington Seafood Lump Crab Meat packaged in 1 lb plastic ups. 40 lb casesListeria monocytogenes identified in finished product testing.
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class II
Medical Device Recall · May 17, 2024
SEASPINE ORTHOPEDICS CORPORATION
Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blaCranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- Class II
Medical Device Recall · May 17, 2024
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
- Class II
Food Recall · May 17, 2024
Universal Bakery Organic Aussie Bites, 30 oz clamshell containerProduct is labeled as gluten free but consumer advocacy group testing revealed results above 20ppm for gluten.