Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 10,401–10,450 of 15,364
- Class II
Food Recall · August 26, 2024
a.) Great Value 8oz Apple Juice in 6pack; PET plastic bottle b.) Great Value 96oz Apple Juice; PET plastic bottle c.) Market Basket 100% apple juice; 64 oz; PET plastic bottle d.) Nice! 100% appleProducts contains inorganic arsenic above action level set in guidance to industry.
- Class II
Food Recall · August 26, 2024
Sour Cherry Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Sour Cherry, Sugar; UPC: 707163026150Products contain undeclared sub ingredient: wheat.
- Class II
Food Recall · August 26, 2024
KODIAK PROTEIN-PACKED POWER WAFFLES BUTTERMILK & VANILLA NET WT 3.35 lb (53.6oz) 1.52kgCreated & distributed by: KODIAK CAKES PARK CITY, UT 84098 UPC 7 05599 01920 3Foreign object - Soft plastic film
- Class II
Food Recall · August 26, 2024
Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPProducts contain undeclared wheat.
- Class II
Medical Device Recall · August 26, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System AnalyzerThyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.
- Class II
Medical Device Recall · August 26, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AIDFirm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.
- Class II
Medical Device Recall · August 23, 2024
Non-ablative Fractional Laser Systems, Model: WFB-01Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 units). All WFB-01 models sold to US customers found to have labeling non-compliances (22 units)
- Class II
Medical Device Recall · August 23, 2024
Young Dental Manufacturing I, LLC
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.
- Class II
Medical Device Recall · August 23, 2024
Diode Laser Hair Removal model: WLA-01All model WLA-01 systems sold to US customers are found to have labeling non-compliances
- Class II
Food Recall · August 23, 2024
La Fontanella Food Products LLC
54th St Blackened Sauce, 9lb bags - 4 bags per case.Soy is in the ingredients but missing from the contains statement.
- Class II
Food Recall · August 23, 2024
Wegmans PECAN BLEND NET WT 16OZ (1LB) 453g Ingredients: Pecans, Cashews, Pistachios, Canola and/or Peanut and/or Cottonseed Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPUndeclared Almonds. The firm was notified by their customer that the product contains undeclared almonds.
- Class II
Medical Device Recall · August 23, 2024
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in false negative results. An end user reported that the OSOM Ultra hCG Combo Test, lot 563L13, produced false negative test results from 2 patient urine samples as confirmed by quantitative hCG and ultrasound. During further root cause testing and investigation, an additional 6 devices were found to produce false negative test results from hCG positive samples.
- Class II
Medical Device Recall · August 23, 2024
Olympus Corporation of the Americas
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- Class II
Medical Device Recall · August 23, 2024
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease atLabeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
- Class I
Food Recall · August 22, 2024
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Murukku 200g UPC:8906087451631. Packaged in box, 13 boxes per cases. Bliss Tree Millet Butter Murukku 400g UPC:8906087452850. Packaged in pouches, 8 pouches per cases.Undeclared sesame and milk
- Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 7Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Class II
Food Recall · August 22, 2024
Blueberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the ingUndeclared soy lecithin and soybean oil on label
- Class II
Medical Device Recall · August 22, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures iDue to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
- Class II
Food Recall · August 22, 2024
Marionberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the iUndeclared soy lecithin and soybean oil on label
- Class II
Food Recall · August 22, 2024
Sri Lakshmi Narasimhar Overseas
Bliss Tree Curry Leaves Butter Murukku 400g UPC:8906087452867. Packaged in pouches, 8 pouches per case.Undeclared milk
- Class II
Drug Recall · August 22, 2024
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02Lack of Assurance of Sterility
- Class II
Medical Device Recall · August 22, 2024
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the colorThe reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. This could lead to a delay in the identification of potential kidney diseases, their evaluation, and/or other conditions associated with elevated protein levels in urine and subsequently a delay in patient treatment.
- Class II
Drug Recall · August 22, 2024
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01Lack of Assurance of Sterility
- Class II
Food Recall · August 22, 2024
American Outdoor Products, Inc.
American Outdoor Products - Astronaut Strawberries, packaged in 0.5oz (14g) metallic plastic pouches. Sold individually or in 6, 12, 40, or 160 count cases. One unit is also included in the OuterspaceElevated levels of lead
- Class II
Drug Recall · August 22, 2024
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02Lack of Assurance of Sterility
- Class II
Drug Recall · August 22, 2024
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01Lack of Assurance of Sterility
- Class II
Drug Recall · August 22, 2024
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01Lack of Assurance of Sterility
- Unclassified
Consumer Product Recall · August 22, 2024
Siemens Industry Inc., of Alpharetta, Georgia
Siemens SolarReady Meter CombosAn interior connection in the recalled Siemens SolarReady Meter Combos can overheat, posing a fire hazard.
- Class II
Drug Recall · August 22, 2024
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04Lack of Assurance of Sterility
- Class II
Food Recall · August 22, 2024
Sri Lakshmi Narasimhar Overseas
Bliss Tree Millet Butter Karasev 200g UPC:8906087451686. Packaged in a box, 13 boxes per case.Undeclared milk
- Class II
Food Recall · August 22, 2024
Sri Lakshmi Narasimhar Overseas
Bliss Tree Moringa Butter Murukku 400g UPC:8906087452836. Packaged in pouches, 8 pouches per case.Undeclared milk
- Class I
Food Recall · August 22, 2024
Terrafina Golden Raisins Net Wt. 10oz (283g) UPC:847938001385. Packaged in a plastic container, 8 containers per case.Undeclared sulfites
- Class II
Drug Recall · August 22, 2024
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01Lack of Assurance of Sterility
- Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 AzurionPotential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 72201Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Class I
Medical Device Recall · August 22, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.Potential installation issue that could result in a fire hazard in the event of an interaction between a damaged Jaco arm and a wheelchair exhibiting electrical leakage.
- Class II
Medical Device Recall · August 22, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost EPotential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Unclassified
Consumer Product Recall · August 22, 2024
Shawshank LEDz Inc., of Gilbert, Arizona
Squeeze Plush Ball ToysThe squeeze ball toy contains a liquid and glitter combination inside a thick membrane. If the membrane is ruptured, the glittery water can splash onto a child's face and body, posing an injury hazard.
- Unclassified
Consumer Product Recall · August 22, 2024
Head Rush Technologies, of Louisville, Colorado
TRUBLUE Speed Auto Belay DevicesThe auto belay device backup brake can fail to activate, posing a fall hazard and risk of serious injury or death.
- Class II
Food Recall · August 21, 2024
MyChai Chai Tea Concentrate KALI, 68 fl. oz. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction sealed during the bottling process. Shelf stable 3 year expiAcidified Chai Tea products are recalled because pH was found above 4.1 and lack production record.
- Class II
Medical Device Recall · August 21, 2024
Vanta Implantable Neurostimulator (INS), Model 977006Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
- Class II
Medical Device Recall · August 21, 2024
Siemens Healthcare Diagnostics, Inc.
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
- Class III
Food Recall · August 21, 2024
MyChai Chai Tea Concentrate Original Double. Product is packaged in the same square 0.5 gallon HDPE plastic bottles and have volumes of 68 fl oz. Ingredients: Water, Sugar, Organic Black Tea, OrganicAcidified Chai Tea product is recalled due to lack production record.
- Class II
Medical Device Recall · August 21, 2024
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
- Class II
Medical Device Recall · August 21, 2024
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
- Class I
Medical Device Recall · August 21, 2024
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line ValveUpdated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
- Class I
Medical Device Recall · August 21, 2024
Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line ValveUpdated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.