The Recall Desk

Archive

May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical
15
Severe
132
High
528
Moderate
72
Low
7

Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

601–700 of 754

  • HighFDA (Devices)·Z-1541-2023·2023-05-10

    LINK SLED Knee System implants recalled for early loosening risk

    Linkbio Corp. recalls 7 LINK SLED knee implants due to risk of early aseptic loosening and increased wear caused by suboptimal surgical technique. Affected units may require earlier-than-expected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2023·2023-05-10

    Orthopedic knee implant system recalled due to early loosening risk

    Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1508-2023·2023-05-10

    Linkbio LINK SLED Knee implant system recalled for surgical technique requirements

    Linkbio Corp. recalls LINK SLED Knee System implants due to risk of early loosening and increased wear caused by improper surgical technique. Updated training and labeling have been issued.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1477-2023·2023-05-10

    Philips ProxiDiagnost N90 radiography systems recalled due to cable damage

    Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.

    Product
    Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2023·2023-05-10

    LINK SLED Knee Prosthesis Recalled for Risk of Premature Failure

    Linkbio Corp. is recalling LINK SLED Knee System prostheses due to risk of early aseptic loosening or increased wear caused by suboptimal surgical technique. The company is providing amended surgical guidelines and training.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1530-2023·2023-05-10

    LINK SLED Knee Implant Recall: Risk of Early Loosening and Revision Surgery

    Linkbio Corp. is recalling 14 LINK SLED Knee implants due to risk of aseptic loosening and increased wear caused by improper surgical technique. The implants may fail earlier than expected, requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1474-2023·2023-05-10

    SafeLight Fiber Optic Cable Recall Due to Assembly Defect

    Stryker Corporation is recalling SafeLight Fiber Optic Cables due to insufficient epoxy on the proximal end, which can cause light output failure and potentially delay surgical procedures.

    Product
    SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Surgical Technique Issues

    Linkbio Corp. is recalling LINK SLED Knee System tibial components due to risk of early aseptic loosening or premature wear caused by suboptimal implant positioning or inadequate cementing during surgery. The manufacturer is updating surgical technique guidance and training.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1548-2023·2023-05-10

    LINK SLED knee implant system surgical technique amendment for aseptic loosening prevention

    Linkbio Corp. is updating surgical technique guidance for the LINK SLED knee implant system to prevent early aseptic loosening or implant wear caused by suboptimal positioning or cementing technique during surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1515-2023·2023-05-10

    LINK SLED Knee Implant Tibial Component: Surgical Technique Amendment

    Linkbio Corp. is issuing updated surgical technique guidance and training for the LINK SLED Knee System tibial component due to risk of early implant loosening or wear from suboptimal positioning or inadequate cementing.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1516-2023·2023-05-10

    LINK SLED Knee System tibial component subject to surgical technique amendment

    A knee implant component is being recalled due to risks of early loosening or increased wear caused by suboptimal implant positioning or inadequate cementing. Manufacturers are providing updated surgical guidance.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1534-2023·2023-05-10

    Knee implant system recalled due to risk of aseptic loosening

    The LINK SLED Knee System has been recalled due to risk of early aseptic loosening and wear caused by suboptimal implant positioning or inadequate cementing technique during surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1475-2023·2023-05-10

    Steris surgical light handle covers may detach during procedures

    Steris surgical light handle covers may detach during use, risking contamination of the sterile field and patient injury. The FDA is recalling approximately 1.4 million affected covers.

    Product
    Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2023·2023-05-10

    Knee Implant System Warning: Risk of Early Loosening Due to Surgical Technique

    Linkbio Corp. is updating labeling and surgical technique training for the LINK SLED Knee System to prevent early aseptic loosening or excessive wear caused by improper implant positioning or inadequate cementing during surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1525-2023·2023-05-10

    LINK SLED Knee Implant Component Recall for Aseptic Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System's all-poly tibial component due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing during surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1507-2023·2023-05-10

    Knee implant component recalled for risk of premature loosening and wear

    Linkbio Corp. is recalling 14 units of LINK SLED Knee System knee implant components due to risk of early loosening and wear caused by suboptimal implant positioning or inadequate cementing technique. Affected patients should contact their surgeon.

    Product
    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2023·2023-05-10

    Laboratory Automation System Firmware May Misassociate Patient Samples

    Inpeco laboratory automation systems have a firmware defect that may cause sample ID mis-association, leading to incorrect test results for electrolyte measurements. Potential consequences include abnormal treatment decisions and serious health complications.

    Product
    Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01, ACP-230-00, ACP-230-01 APT-207-00, APT-207-01, APT-230-00, APT-230-01 F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2023·2023-05-10

    Knee implant tibial component recalled for aseptic loosening risk

    Linkbio Corp. recalls LINK SLED Knee System tibial component due to risks of early aseptic loosening and implant wear from improper surgical positioning or cementing technique.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1535-2023·2023-05-10

    Knee Implant Recalled for Inadequate Surgical Technique Guidance

    Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0806-2023·2023-05-10

    Breakfast cookies recalled due to undeclared sesame allergen

    Bakery 37 Inc is recalling Blue Moon Bakery Legendary Breakfast Cookies because they contain undeclared sesame. The cookies were distributed in Oregon and may pose a risk to consumers with sesame allergies.

    Product
    Blue Moon Bakery Legendary Breakfast Cookie identified as a 3oz (84g) cookie with pecans, flax and cranberries is frozen, packed in a clear sealed bag. Sesame seeds is identified in the ingredients statement. Advisory statement reads, "Contains: tree nuts, milk and eggs. Made in
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1549-2023·2023-05-10

    LINK SLED Knee System recalls due to implant loosening risk

    Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen prematurely due to improper positioning or cementing technique. Enhanced surgical training is being provided to prevent early device failure.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1536-2023·2023-05-10

    Knee Implant System Recalled for Premature Loosening and Wear Risk

    Linkbio Corp. is recalling LINK SLED Knee System implants that may loosen or wear prematurely due to improper surgical positioning or cementing, potentially requiring revision surgery. Updated surgical technique guidance is being provided.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1538-2023·2023-05-10

    LINK SLED Knee Implant Component Recalled for Aseptic Loosening Risk

    The LINK SLED Knee System tibial component is being recalled due to risk of aseptic loosening caused by improper implant positioning or cementing technique, which could lead to early implant failure requiring revision surgery.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1559-2023·2023-05-10

    Laboratory automation module firmware may cause sample misidentification

    A firmware bug in Inpeco laboratory automation modules may cause sample misidentification, leading to incorrect electrolyte test results and potential treatment errors.

    Product
    Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00, APT-253-00 ACP-201-00, FLX-201-10, FLX-253-10, FLX-253-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0805-2023·2023-05-10

    Blue Moon Bakery Choconut Breakfast Cookie Recalled for Undeclared Sesame Allergen

    Blue Moon Bakery Choconut Breakfast Cookie is being recalled because sesame is not listed in the Contains statement on the label, despite being present in the product. Consumers allergic to sesame may consume the product unknowingly.

    Product
    Blue Moon Bakery Choconut Breakfast Cookie identified as a 3oz (84g) cookie with coconut and dark chocolate is frozen, packed in a clear sealed bag. UPC 852240004016. Sesame seeds is identified in the ingredients statement. Advisory statement reads "Contains: tree nuts, soy and e
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1499-2023·2023-05-10

    Walgreens assorted bandages recalled for undisclosed ingredient in adhesive

    ASO LLC is recalling Walgreens assorted bandages (item 196568) distributed nationwide due to benzalkonium chloride in the adhesive pad that is not disclosed on the labeling.

    Product
    WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2023·2023-05-10

    Knee implant system recalled due to aseptic loosening and wear risk

    Linkbio Corp. is recalling the LINK SLED Knee System due to risk of early aseptic loosening and increased wear caused by improper surgical technique or positioning. The issue may require early revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1500-2023·2023-05-10

    GE Healthcare radiological imaging system patient information mismatch

    GE Healthcare's Centricity PACS-IW radiological imaging system can mismatch patient information when correcting study details. 17 units distributed worldwide are affected.

    Product
    Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1563-2023·2023-05-10

    Laboratory automation system firmware recalled for sample mis-identification

    Inpeco is recalling Alinity h laboratory automation system firmware that may mis-identify samples, causing incorrect electrolyte test results that could lead to improper patient treatment.

    Product
    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2023·2023-05-10

    CryoTreQ Aa ophthalmic instrument recalled for risk of sudden disassembly

    Beaver Visitec is recalling the CryoTreQ Aa ophthalmic surgical instrument due to risk of sudden disassembly during use. Device disassembly during cryosurgery could cause permanent vision impairment.

    Product
    CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1519-2023·2023-05-10

    LINK SLED Knee System Tibial Component Recall Due to Early Loosening Risk

    Linkbio Corp. is recalling the LINK SLED Knee System ALL POLY TIBIAL COMPONENT due to risk of early aseptic loosening or increased wear from suboptimal surgical placement or cementing, which may require early revision surgery.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1514-2023·2023-05-10

    Knee implant recalled due to early aseptic loosening risk from surgical technique

    LINK SLED Knee System tibial components are being recalled due to risk of early aseptic loosening and increased wear from suboptimal implant positioning or inadequate cementing technique. Surgical technique guidance is being issued.

    Product
    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0798-2023·2023-05-10

    Cargill Soy Flour Recalled for Possible Gluten Contamination

    Cargill is recalling PROSANTE soy flour products labeled gluten-free because they may contain gluten levels above 20 ppm, the FDA's regulatory threshold for gluten-free labeling. Products were distributed nationwide and internationally.

    Product
    PROSANTE TSOYFLR 7P MNCD 25LB BG/40P, PROSANTE TSOYFLR 7P MNCD 50LB BG, 25 lb and 50lb paper bags
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0799-2023·2023-05-10

    Cargill recalls bulk ingredient for gluten exceeding safe levels

    Cargill recalls 174,600 lbs of bulk ingredient distributed nationwide and internationally. Products labeled gluten-free contain gluten levels exceeding 20 ppm.

    Product
    PROSANTE TVGPTN 7B MNCD 50LB BG, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0821-2023·2023-05-10

    H-E-B Bakery Two-Bite Brownies Recalled for Potential Rubber Fragments

    Give & Go Prepared Foods is recalling H-E-B Bakery Two-Bite Brownies due to potential soft rubber fragments that could pose a choking hazard. The recall affects 3,607 cases distributed in Texas.

    Product
    H-E-B Bakery Two-Bite Brownies Net Wt. 12 Oz (340g) UPC 041220109517 packaged in a clear clam shell plastic container
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0797-2023·2023-05-10

    Cargill recalls PROSANTE product with undeclared gluten in gluten-free labeling

    Cargill is recalling PROSANTE TVGPTN 5B product because items labeled gluten-free may contain gluten above 20 ppm. The recall affects 496,200 lbs distributed nationwide and internationally.

    Product
    PROSANTE TVGPTN 5B MNCD 50LB BG, PROSANTE TVGPTN 5B MNCD 50LB BG/21P, paper bag
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0559-2023·2023-05-10

    Drug Recall: Glimepiride 4 mg for Manufacturing Practice Deviations

    PD-Rx Pharmaceuticals is recalling 186 bottles of Glimepiride USP 4 mg due to manufacturing deviations. Patients using this medication should contact their healthcare provider to verify if their supply is affected.

    Product
    Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1556-2023·2023-05-10

    VITROS 5600 system pack opener assembly may not function properly

    The MicroTip Pack Opener Assembly on VITROS 5600 systems may fail to remove or replace pack caps properly, making packs unusable and delaying clinical test results. Approximately 4,895 units were distributed.

    Product
    VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnosti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0778-2023·2023-05-10

    Sofrito Marinating Sauce recalled for improper storage conditions

    20-100 Delicious Seasoning LLC recalls Sofrito Marinating Sauce because the product was not stored refrigerated as required. Consumers should not consume the product.

    Product
    Sofrito Marinating Sauce, 100% All Natural Ingredients (Caribbean Seasoning), Net Wt 16 oz. (460g), 8 oz. (230g) and 32(920g) oz. Glass Jar. Manufactured and Distributed by 20100 Seasoning LLC. Keep Refrigerated.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0808-2023·2023-05-10

    Atkins Milk Chocolate Delight Protein Shakes Recalled for Spoilage Risk

    Simply Good Foods is recalling Atkins Milk Chocolate Delight Protein Shakes nationwide due to post-processing contamination that may cause spoilage. Affected products have lot numbers SA2208P3F6 (exp. 07/27/23) or SA2210P3F6 (exp. 07/29/23).

    Product
    Atkins Milk Chocolate Delight Protein Rich Shakes, NET WT. 44 oz (4 / 11oz), 4 Tetra Packs per carton, UPC 637480065016, Distributed exclusively by Simply Good Foods USA, Inc. Denver, CO 80202, 1-800-6-ATKINS
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0557-2023·2023-05-10

    Drug Recall: Montelukast Sodium Tablets Due to Manufacturing Deviations

    PD-Rx Pharmaceuticals has recalled 352 bottles of Montelukast Sodium USP 10 mg tablets distributed nationwide due to manufacturing process deviations. This was a voluntary recall by the firm.

    Product
    Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1545-2023·2023-05-10

    LINK SLED Knee Implant Surgical Technique Update Required

    The LINK SLED Knee System requires updated surgical technique training due to risks of aseptic loosening and implant wear when improperly positioned or cemented. The manufacturer is issuing reinforced surgical guidelines and training to prevent unsatisfactory outcomes.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0561-2023·2023-05-10

    Simvastatin 40 mg recalled nationwide for manufacturing quality deviations

    PD-Rx Pharmaceuticals voluntarily recalled Simvastatin 40 mg due to manufacturing quality issues. The recall affects 393 bottles distributed nationwide, with affected lot expiration dates ranging from May 2023 to April 2024.

    Product
    Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1557-2023·2023-05-10

    VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect

    Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.

    Product
    VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2023·2023-05-10

    VITROS XT 7600 Analyzer Pack Opener May Not Remove Reagent Pack Caps

    The MicroTip Pack Opener Assembly in VITROS XT 7600 laboratory analyzers may fail to properly remove or replace reagent pack caps, potentially causing unusable packs and delayed test results. Approximately 2,001 affected units were distributed nationwide and internationally.

    Product
    VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1506-2023·2023-05-10

    DERMLITE DL4W Medical Device Recalled for Serial Number Labeling Discrepancy

    DermLite LLC is recalling DERMLITE DL4W diagnostic devices due to incorrect package labeling. The serial number on the package differs from the serial number on the product itself.

    Product
    DERMLITE DL4W, REF: DL4W, Rx Only MD, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0556-2023·2023-05-10

    Lidocaine Patch 5% Recalled for Typographical Error on Label

    Bryant Ranch Prepack is recalling Lidocaine Patch 5% nationwide due to a typographical error on product labels. The labels incorrectly state 'tablet' instead of 'patch', creating potential confusion about the dosage form.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0813-2023·2023-05-10

    Signature Select Oat & Nuts Bread Recalled for Potential Tree Nut Cross-Contamination

    Albertsons Companies LLC is recalling Signature Select Oat & Nuts Bread (20 oz) due to potential undeclared tree nut allergens from cross-contamination. Consumers with tree nut allergies should not consume affected products.

    Product
    Signature Select Oat & Nuts Bread NET WT 20 OZ (1 LB 8 OZ) 680 g Ingredients: Unbleached enriched wheat flour (wheat flour, malted barley flour, reduced iron, niacin, thiamine, mononitrate, riboflavin, folic acid), water, whole grain, oats, liquid sugar, yeast, hazelnuts, molasse
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0558-2023·2023-05-10

    Simvastatin USP Tablets Recalled Due to Manufacturing Quality Deviations

    PD-Rx Pharmaceuticals is recalling Simvastatin USP 10 mg tablets due to manufacturing quality deviations. The recall affects 37 bottles distributed nationwide.

    Product
    Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0814-2023·2023-05-10

    Nuts & Grain Bread Recalled for Undeclared Tree Nut Cross Contamination

    Signature Select Nuts & Grain Bread may contain undeclared tree nuts from potential cross contamination. The product is distributed in Western U.S. states and poses a risk to consumers with tree nut allergies.

    Product
    Signature Select Nuts & Grain Bread NET WT 20 OZ (1 LB 8 OZ) 680 g Ingredients: Unbleached enriched wheat flour (wheat flour, malted barley flour, reduced iron, niacin, thiamine, mononitrate, riboflavin, folic acid), water, walnuts, whole grain bulgur wheat, whole grain oats, sun
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0811-2023·2023-05-10

    PreProtein Liquid Dietary Supplement Recalled for Bloated Bottles

    Novis PR, LLC is recalling PreProtein Liquid Predigested Protein dietary supplement because certain bottles are bloated. The recall affects approximately 4,106 units from lot 230118.

    Product
    PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0565-2023·2023-05-10

    Advil Dual Action Pain Reliever Recalled for Storage Temperature Deviation

    Family Dollar Stores is recalling Advil Dual Action pain reliever tablets (36-caplet bottles, SKU 0902867) nationwide because the product was stored outside labeled temperature requirements.

    Product
    Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0563-2023·2023-05-10

    Advil Ibuprofen Tablets Recalled for Storage Temperature Deviation

    Family Dollar Stores is recalling Advil Ibuprofen 200 mg tablets due to a storage temperature deviation during manufacturing and distribution. No illnesses have been reported.

    Product
    Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2023·2023-05-10

    Knee implant system amended surgical technique and training guidance

    Linkbio Corp. is issuing amended surgical technique guidance for its knee implant system to prevent early loosening and wear caused by improper positioning or inadequate cementing.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1482-2023·2023-05-10

    Hill-Rom Pro+ Hospital Mattress Covers Recalled for Delamination Risk

    Baxter is recalling Hill-Rom pro+ mattress covers that may delaminate, allowing fluid to seep into the mattress. No injuries have been reported.

    Product
    Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2023·2023-05-10

    LINK SLED Knee System Tibial Implant Aseptic Loosening Risk

    The LINK SLED Knee System tibial implant may experience early aseptic loosening if not positioned or cemented properly during surgery. Linkbio recommends updated surgical technique training for optimal implant placement.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1558-2023·2023-05-10

    DeVilbiss Healthcare 1025 Series Oxygen Concentrator Instruction Manual Update

    DeVilbiss Healthcare is updating the instruction manual for its 1025 Series Oxygen Concentrator to comply with IEC-60101-1 standard labeling requirements. This recall affects 143,397 units distributed nationwide and worldwide.

    Product
    DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V331000·2023-05-09

    Braun Ambulances Recall 2019-2023 Models Due to Brake Line Wear

    Braun is recalling 2019-2023 ambulances because suspension systems may wear brake lines, risking rear brake loss and crashes.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES EXPRESS PLUS TYPE I, CHIEF XL TYPE I, LIBERTY TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E038000·2023-05-09

    Advance Recalls Carquest Lower Ball Joints Due to Steering Control Risk

    Advance Stores Company is recalling specific Carquest lower ball joints that may separate from the steering knuckle, potentially causing a loss of steering control.

    Product
    SUSPENSION:FRONT:CONTROL ARM:LOWER BALL JOINT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V332000·2023-05-09

    E-One Recalls 2022-2023 Cyclone N and Typhoon N Aerial Vehicles

    E-One is recalling 2022-2023 Cyclone N and Typhoon N vehicles because the aerial device sensor may fail, risking operator injury.

    Product
    E-ONE — E-ONE CYCLONE N, TYPHOON N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V333000·2023-05-09

    School bus structural joint defect poses crash protection risk

    Daimler Trucks North America is recalling Thomas Built school buses due to potentially insufficient rear interior joint strength. Dealers will add fasteners to reinforce the joints at no charge.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V330000·2023-05-08

    2024 Thomas Built Buses Recall for Insufficient Rear Joint Strength

    Daimler Trucks North America is recalling 2024 Thomas Built SAF-T-LINER C2 school buses because a rear exterior joint may have insufficient strength, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V328000·2023-05-08

    Triple E Recalls 2023 Motorhomes Due to Electrical Fire Risk

    Triple E is recalling 2023 Unity and Wonder motorhomes because exposed copper at the GFCI exterior receptacle can cause electrical shorts, arcing, and fire.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V329000·2023-05-08

    Ferrari Recalls 2022-2023 296 Models Due to Fuel Leak Fire Risk

    Ferrari is recalling 2022-2023 296 vehicles because a fuel tank pipe may corrode and leak, increasing fire risk. Owners should not drive until repaired.

    Product
    FERRARI — FERRARI 296
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V327000·2023-05-05

    2023 Airstream Atlas Motorhomes Recalled for Electrical Fire Risk

    Airstream is recalling 2023 Atlas motorhomes due to undersized fuses that may allow wiring to overheat and increase fire risk. Dealers will replace the fuse and install a new circuit.

    Product
    AIRSTREAM — AIRSTREAM ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V322000·2023-05-04

    2023 International MV Trucks: Driveshaft Weld Defect Recall

    Navistar is recalling 49 2023 International MV trucks because the driveshaft tube seam weld may separate or tear, causing sudden loss of drive power and increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL MV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23751·2023-05-04

    Polaris Model Year 2022-2023 Snowmobiles Recalled for Fire Hazard

    Polaris is recalling about 14,885 Model Year 2022-2023 MATRYX RMK KHAOS and PRO snowmobiles. When the rider engages the throttle and brake simultaneously, the brake system can overheat, posing a fire hazard and risk of burn injuries.

    Product
    Model Year 2022-2023 MATRYX RMK KHAOS and PRO Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E037000·2023-05-04

    Continental Electric Brake System Modules Recalled for Internal Leak Risk

    Continental Automotive Systems is recalling specific Electric Brake System modules where manufacturing defects may cause internal leaks, potentially increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V323000·2023-05-04

    Jayco Recalls 2022 Motorhomes Due to Fuel Tank Corrosion Risk

    Jayco is recalling 2022 Esteem, Odyssey, Redhawk, and Greyhawk motorhomes because fuel tank paint may peel, causing corrosion and potential fuel leaks.

    Product
    JAYCO — JAYCO, ENTEGRA REDHAWK, GREYHAWK, ODYSSEY, ESTEEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V326000·2023-05-04

    Altec Recalls 2017-2022 Digger Derricks Due to Missing Hardware

    Altec is recalling 2017-2022 Digger Derricks because missing hardware may allow the auger extension bar to detach, increasing injury risk.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23C004000·2023-05-04

    Baby Trend Recalls Hybrid 3-in-1 Booster Seats Due to Latch Webbing Fraying

    Baby Trend is recalling approximately 2,600 Hybrid 3-in-1 Combination Booster Seats because the latch assembly webbing may fray, potentially failing to restrain a child in a crash.

    Product
    CHILD SEAT:LATCH STRAP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V320000·2023-05-04

    Gas Leak Risk in Horse Trailers and Sprinter Vans with Faulty Cooktops

    Outback Customs is recalling certain 2020-2023 horse trailers and 2021-2022 Sprinter Vans equipped with SDS2 cooktops. Aluminum burner tubes may fracture and leak gas, increasing fire risk.

    Product
    OUTBACK CUSTOM — OUTBACK CUSTOM, FEATHERLITE, 4 STAR SPRINTER, HORSE TRAILER, DODGE RAM RCA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V324000·2023-05-04

    2022-2023 Land Rover Range Rover Second-Row Armrest Latch Failure Recall

    Jaguar Land Rover is recalling 2022-2023 Range Rover vehicles because the second-row armrest latch may fail, allowing unsecured objects to strike occupants during a crash. Dealers will replace the locking arm free of charge.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V317000·2023-05-04

    Ferrara Recalls 2022 Fire Trucks Due to Winch Remote Water Intrusion

    Ferrara Fire Apparatus is recalling 2022 Ultra and Inferno fire trucks because water in the winch remote can cause corrosion and unintentional operation.

    Product
    FERRARA — FERRARA ULTRA, INFERNO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V321000·2023-05-04

    Outback Recalls Horse Trailers Due to Potential Gas Leak Risk

    Outback Customs is recalling 2018-2020 Elite and Cimarron horse trailers because a gas leak from the stove may increase fire risk.

    Product
    ELITE — ELITE, CIMARRON HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V319000·2023-05-04

    PJ Trailers Coupler May Loosen and Separate, Posing Crash Risk

    PJ Trailers is recalling certain 2022-2024 trailers with Demco EZ Latch Gooseneck Couplers because the mounting bolts may loosen, causing the coupler to separate and creating a crash risk.

    Product
    PJ TRAILERS — PJ TRAILERS LY, LD, LS, LX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V318000·2023-05-04

    2024 Entegra Vision motorhome brake caliper bolts may be loose

    Jayco is recalling 2024 Entegra Vision and related motorhomes due to rear brake caliper attachment bolts that may not be properly tightened. Loose bolts could damage the wheel or brake lines, reducing brake performance and increasing crash risk.

    Product
    JAYCO — JAYCO, ENTEGRA ALANTE, VISION XL, VISION, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V325000·2023-05-04

    Entegra and Jayco Class B RVs Recalled: Fuel Hose Clamp Defect

    Jayco, Inc. is recalling certain 2021-2024 Class B recreational vehicles. A fuel hose clamp may be inadequate, potentially causing gasoline leaks and increasing fire risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO ETHOS, SWIFT, SOLSTICE, EXPANSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23752·2023-05-04

    L.O.L. Surprise! Metal Doll Pins Recalled for Excessive Lead Paint

    Culture Fly is recalling approximately 6,600 L.O.L. Surprise! Trick or Treat subscription boxes sold with metal doll pins because the paint on the pins contains lead levels that exceed the federal lead paint ban, posing a lead poisoning hazard to young children.

    Product
    L.O.L. Surprise! Trick or Treat subscription boxes sold with Metal Doll Pins
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23193·2023-05-04

    Walker Edison Twin Over Twin Bunk Beds Recalled for Fall Hazards

    Walker Edison Furniture is recalling about 121,000 Twin Over Twin Bunk Beds because the wooden slats supporting the beds can break while in use, posing fall and impact hazards. The company has received 14 incident reports, including one report of minor injuries.

    Product
    Twin Over Twin Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23754·2023-05-04

    Children's White Robes Recalled for Flammability Standards Violation

    The Company Store is recalling about 930 children's white robes sold online from September 2021 through November 2022 because they fail to meet federal flammability standards for children's sleepwear, posing a burn injury risk.

    Product
    Children's white robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23195·2023-05-04

    Ricky Powersports Youth ATVs recalled for safety standard violations

    About 570 Ricky Powersports youth ATVs fail to meet federal safety standards, including parking brake and labeling requirements. The defects pose a risk of serious injury or death.

    Product
    Ricky Powersports Youth All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23753·2023-05-04

    Sahara Folding Food Dehydrators Recalled for Fire Hazard

    Berkshire Innovations is recalling about 990 Sahara Folding Food Dehydrators because the heater fan can fail and cause the unit to overheat, posing a fire hazard. No injuries or property damage have been reported.

    Product
    Sahara Folding Food Dehydrators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23196·2023-05-04

    Severe Weather Doorglass Inserts Recalled Due to Wind-Borne Debris Risk

    ODL Inc. is recalling Severe Weather Doorglass Inserts sold at Home Depot and Lowe's because the adhesive bond can separate during hurricanes, creating a risk of injury and property damage from windborne debris.

    Product
    Severe Weather Doorglass Inserts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0802-2023·2023-05-03

    Savor Imports IQF Raspberries recalled for potential Hepatitis A contamination

    Savor Imports IQF Whole Raspberries (Lot 20220210) are recalled nationwide due to potential Hepatitis A contamination. Consumers should not eat the product and should return or discard it.

    Product
    Savor Imports IQF Whole Raspberries; Net Wt 2-5lb; MFG# 341798; UPC: 10684476003771
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0760-2023·2023-05-03

    Patagonia Foods Blackberries Recalled for Possible Hepatitis A

    Patagonia Foods is recalling frozen blackberries (Lot 20422) distributed in six U.S. states due to possible Hepatitis A contamination. Consumers should not consume the product.

    Product
    Patagonia Foods 3610100 Blackberry IQF Product of Mexico Net Wt. 30 LBS. (13.61 kg) Production/Lot Code 20422 Distributed By: Patagonia Foods, LLC. San Luis Obispo, CA 93401 patagoniafoods.com
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0755-2023·2023-05-03

    Premium Makoto Honey Ginger Salad Kit Recalled for Listeria Contamination

    Fresh Express is recalling Premium Makoto Honey Ginger Salad Kits distributed in five states because the product tested positive for Listeria monocytogenes. Consumers should not consume this product.

    Product
    PREMIUM MAKOTO HONEY GINGER SALAD KIT TOTAL NET WT 8.75 OZ (248g) DRESSING 2.03 FL OZ (60 mL) SALAD & TOPPING 6.5 OZ (184g) DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., LAKELAND, FL 33802 UPC 0 41415 18386 5
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·23V314000·2023-05-03

    Bentley Recalls Flying Spur Vehicles Due to Screen Bracket Defect

    Bentley is recalling 2021-2023 Flying Spur vehicles because an incorrectly installed rear entertainment screen bracket could become a projectile in a crash, increasing injury risk.

    Product
    BENTLEY — BENTLEY FLYING SPUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0754-2023·2023-05-03

    Fresh Express Chopped Kit Recalled for Listeria monocytogenes

    Fresh Express Chopped Kit Chipotle Cheddar salad has been recalled because it tested positive for Listeria monocytogenes. The product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh Express Chopped Kit Chipotle Cheddar TOTAL NET WT. 11.3 oz (320G) SALAD TOPPINGS NET WT 9.1 oz (258Gg) DRESSING 2.3 fl. oz. (68 mL)/NET WT 2.2oz (62g) FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30604 9
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0749-2023·2023-05-03

    Lamb Weston Frozen Hash Brown Patties Recalled for Undeclared Wheat

    Lamb Weston Sales is recalling frozen hash brown patties due to undeclared wheat allergen. The recall affects approximately 1605 cases distributed to foodservice customers across multiple states and international locations.

    Product
    G5300 Lamb's Supreme Hash Brown Patties, Frozen, 24 patties packed in blank unlabeled tray, 12 trays packaged in one case. Net Wt. 33.75LB (15.30kg). UPC 1 00 44979 75300 7. The ingredients statement read: POTATOES, VEGETABLE OIL (CONTAINS OR OR MORE OF THE FOLLOWING: CANOLA, PA
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-0753-2023·2023-05-03

    Fresh EXPRESS Lettuce Salad Kit Recalled for Listeria

    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce has been recalled due to testing positive for Listeria monocytogenes. The affected product was distributed to Florida, Georgia, North Carolina, South Carolina, and Virginia.

    Product
    Fresh EXPRESS Chopped Kit Caesar Romaine Lettuce TOTAL NET WT. 9.4 OZ (266g) SALAD & TOPPINGS: NET WT. 6.9 OZ (196g) DRESSING 2.5 fl. oz. (74 mL)/NET WT 2.5 oz. (71g) fresh express incorporated P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30919 4
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0751-2023·2023-05-03

    Creekside Mallow Mint Marshmallows Recalled for Undeclared Milk Allergen

    Creekside Mallow Chocolate Chip Mint Marshmallows are recalled due to butterfat in the chocolate chips not being accompanied by a milk declaration in the Contains statement. The product affects 2,800 packages distributed in Washington and poses a risk to consumers with milk allergies.

    Product
    Creekside Mallow Chocolate Chip Mint Marshmallows, packed in a Stand Up Flexible Pouch (Bag), Net wt. 3.9oz. UPC 7 09951 63271 0. Manufactured by Creekside Mallow LLC Caldwell, ID. www.creeksidemallow.com. The label declares: INGREDIENTS: CORN SYRUP ***SUGAR, WATER, CHOCOLATE CH
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V315000·2023-05-03

    Capacity Recalls 2022 TJ Series Trucks Due to Missing Seat Clip

    Capacity of Texas is recalling 2022 TJ 5000, 6500, and 9000 trucks because a missing safety clip on the passenger jump seat could allow it to fall, increasing injury risk.

    Product
    CAPACITY — CAPACITY TJ 6500, TJ 5000, TJ 9000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V313000·2023-05-03

    2022 Porsche 911 Carrera recalled for missing body welds

    Porsche is recalling certain 2022 911 Carrera and related models due to missing welds in the vehicle body from a production process error. Missing welds could reduce crash protection and increase the risk of injury.

    Product
    PORSCHE — PORSCHE 911 CARRERA, 911 CARRERA S, TAYCAN TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V312000·2023-05-03

    Volkswagen ID.4 Door Handles May Open Unexpectedly Due to Water Intrusion

    Certain 2021-2022 Volkswagen ID.4 vehicles have door handles that may allow water to enter the circuit board assembly, potentially causing doors to open unexpectedly while driving. Volkswagen will update vehicle software and inspect door handles at no cost to owners.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2023·2023-05-03

    Biopsy forceps may fail to open when endoscope is bent

    Biopsy forceps may become unable to open when the endoscope shaft is bent approximately 90 degrees. Additional bending of the forceps shaft can prevent opening entirely.

    Product
    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2023·2023-05-03

    Digital X-ray System Arm May Break, Posing Injury Risk

    FUJIFILM's FDR AQRO digital X-ray system arm may break during use. The tube head support is susceptible to failure, which could cause serious harm to patients or operators.

    Product
    FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0769-2023·2023-05-03

    Popped water lily seeds recalled due to undeclared milk

    Karma Spices and Trading Company is recalling Karma White Cheddar Cheese Popped Water Lily Seeds because the product contains undeclared milk. The recall affects 1,423 units distributed in Michigan and online.

    Product
    Karma White Cheddar Cheese Popped Water Lily Seeds packed in 1.5oz pouches UPC: 617201892589
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·23V311000·2023-05-03

    2022 Winnebago Micro Minnie Solar Panel Fasteners May Loosen Causing Detachment

    Winnebago is recalling 2022 Micro Minnie travel trailers due to loose solar panel mounting hardware that may cause the solar panel to detach. A detached panel can become a road hazard and increase crash risk.

    Product
    WINNEBAGO — WINNEBAGO MICRO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2023.