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.

301–400 of 754

  • HighFDA (Drugs)·D-0606-2023·2023-05-24

    Cefepime for Injection Recalled Due to Sterility Assurance Concerns

    The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-009-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0621-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling approximately 1.3 million vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility during manufacturing.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-576-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0619-2023·2023-05-24

    Injectable Ceftriaxone Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.

    Product
    Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0597-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Assurance Failure

    Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-207-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0613-2023·2023-05-24

    Ceftriaxone Injectable Recalled Due to Lack of Sterility Assurance

    Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.

    Product
    Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-213-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0580-2023·2023-05-24

    Ampicillin for Injection Recall Due to Sterility Assurance Concerns

    Astral SteriTech is recalling 70,040 vials of Ampicillin for Injection nationwide due to lack of assurance of sterility in the manufacturing process.

    Product
    Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-220-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2023·2023-05-24

    Teleflex D-Stat Flowable Hemostat Recalled for Expired Diluent Vial

    Teleflex is recalling D-Stat Flowable Hemostat units with expired diluent vials that cannot assure sterility. No illnesses or injuries have been reported.

    Product
    Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2023·2023-05-24

    Vapor-Clean Anesthetic Filter Recalled Due to Manufacturing Leakage Defect

    Dynasthetics LLC is recalling the Vapor-Clean anesthetic filter due to a manufacturing issue that may result in filter leakage. The defect could allow unwanted anesthetic gases to reach patients during anesthesia delivery.

    Product
    Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0617-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Concerns

    FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.

    Product
    Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V365000·2023-05-24

    Loose Seat Belt Attachment in Winnebago and Itasca Motorhomes

    Winnebago and Itasca recall certain 2020-2023 motorhomes due to improperly tightened seat belt attachments that may fail to restrain occupants in a crash. Dealers will tighten fasteners free of charge.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA INSPIRE, ADVENTURER, VISTA, SHELL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0628-2023·2023-05-24

    Antibiotic Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-218-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2023·2023-05-24

    Ampicillin and Sulbactam for Injection recalled nationwide for sterility assurance deficiency

    Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0615-2023·2023-05-24

    Ceftriaxone for Injection Recalled Due to Sterility Assurance Issue

    Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-215-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0607-2023·2023-05-24

    Cefepime for Injection recalled nationwide for lack of sterility assurance

    Astral SteriTech is recalling 41,320 vials of Cefepime for Injection (1 gram) nationwide because the manufacturer cannot assure the product meets required sterility standards for safe injection.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-209-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0591-2023·2023-05-24

    Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns

    Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2023·2023-05-24

    Beckman Coulter Urine Analyzer Software Flag Display Issue Affects Carryover Detection

    Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover contamination.

    Product
    DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0636-2023·2023-05-24

    Vancomycin injection recalled for lack of sterility assurance

    Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.

    Product
    VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0574-2023·2023-05-24

    Lorazepam injection vials recalled for elevated impurities and degradation

    Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2023·2023-05-24

    Injectable Antibiotic Recalled for Lack of Sterility Assurance

    Astral SteriTech is recalling 51,280 vials of Cefepime for Injection nationwide because the manufacturer cannot assure that all vials meet sterility requirements. The product is distributed across the United States.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Critical Care Bethlehem, PA 18017 USA, NDC 66794-210-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2023·2023-05-24

    Heparin Sodium and Dextrose Injection Recalled Due to Subpotency

    B. Braun Medical Inc. is recalling 1,380 units of Heparin Sodium in Dextrose injection because the product is subpotent with lower anti-factor IIa potency than specified.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2023·2023-05-24

    YelloPort Elite Optical Trocars Recalled for Sterility Assurance Failure

    YelloPort Elite optical trocars (3,405 units) are recalled because sterility assurance cannot be guaranteed. The surgical instruments were distributed in Massachusetts.

    Product
    YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0630-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled Due to Sterility Assurance Issue

    Approximately 936,680 vials of Piperacillin and Tazobactam for Injection are being recalled nationwide due to lack of assurance of sterility. All affected lots remain within their expiration dates.

    Product
    Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0629-2023·2023-05-24

    Piperacillin and Tazobactam for Injection Recalled for Lack of Sterility Assurance

    The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.

    Product
    Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2023·2023-05-24

    Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance

    IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.

    Product
    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0889-2023·2023-05-24

    Ellenos Greek Yogurt recalled for undeclared egg allergen

    REAL GREEK LLC is recalling Ellenos Vanilla Bean Greek Yogurt 4oz cups due to mislabeling: Lemon Curd yogurt was packaged as Vanilla Bean, and egg is not declared on the label.

    Product
    The Vanilla Bean Greek Yogurt 4oz cup is part of the 12-Pack case, Ellenos Greek Yogurt, Grade A Milk, Costco Item Code: # 1340833. The 12-Pack case has the UPC 8 57290 00617 1. The Vanilla Bean Greek Yogurt 4oz cup has the UPC 8 57290 00620 1. Label declares Ingredients: Y
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0891-2023·2023-05-24

    Duke's Bayou Remoulade Sauce Mislabeled as Gluten-Free Despite Wheat Content

    Duke's Southern Sauces Bayou Remoulade sauce is mislabeled as gluten-free but contains wheat in its soy sauce ingredient. Consumers relying on the false gluten-free label could be harmed.

    Product
    Duke's SOUTHERN SAUCES BAYOU REMOULADE NET WT. 10 FL OZ (296 ml) GLUTEN FREE INGREDIENTS:***SOY SAUCE (WHEAT, SOYBEANS, AND SALT)***CONTAINS SOY, WHEAT, EGGS SAUER BRANDS, INC. RICHMOND, VA 23220 UPC x 52500 08582 7
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0886-2023·2023-05-24

    Dietary supplement Microbiome Rejuvenate recalled for glass fragment contamination

    Big Bold Health is recalling Microbiome Rejuvenate dietary supplement bottles due to glass fragment contamination. The recall affects 1,087 bottles distributed nationwide and internationally.

    Product
    Microbiome Rejuvenate dietary supplement, 60 capsules per bottle, UPC: 8 50033 36201 5. Distributed by Big Bold Health, Bainbridge Island, WA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0646-2023·2023-05-24

    FDA Recalls Fentanyl and Ropivacaine Injectable for Lack of Sterility Assurance

    Apollo Care, LLC recalled 308 bags of fentanyl and ropivacaine injectable solution due to lack of assurance of sterility. The affected product was distributed in Missouri only.

    Product
    FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0625-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Piperacillin and Tazobactam for Injection due to lack of sterility assurance. The recalled product may pose an infection risk to patients if used.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0592-2023·2023-05-24

    Ampicillin-Sulbactam Injection Recalled Due to Sterility Concerns

    FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0627-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech recalls 223,590 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assured sterility. Patients and healthcare providers should stop use and consult their provider.

    Product
    Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0620-2023·2023-05-24

    Ceftriaxone Injection Recalled Over Sterility Assurance Defect

    Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.

    Product
    Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0635-2023·2023-05-24

    Apollo Care Ketamine Injection Recalled Due to Sterility Assurance Defect

    Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.

    Product
    Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0593-2023·2023-05-24

    FDA Recalls Ampicillin and Sulbactam Injectable Over Sterility Defect

    The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.

    Product
    Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0644-2023·2023-05-24

    Norepinephrine injectable recalled for lack of sterility assurance

    Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.

    Product
    Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0626-2023·2023-05-24

    Piperacillin and Tazobactam Injectable: Lack of Sterility Assurance Recall

    Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.

    Product
    Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2023·2023-05-24

    Injectable Vancomycin Recalled Due to Lack of Sterility Assurance

    Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in Missouri.

    Product
    VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0595-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Due to Sterility Concerns

    Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0610-2023·2023-05-24

    Cefepime Injectable Antibiotic Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was distributed nationwide.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0583-2023·2023-05-24

    Ampicillin for injection recalled nationwide due to sterility concerns

    Ampicillin for Injection (2g per vial) is being recalled nationwide because the manufacturer cannot assure the product meets sterility standards. All 45,160 affected vials in circulation are included.

    Product
    Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0575-2023·2023-05-24

    ADMELOG Insulin Lispro Recalled for Malformed Seal Defect

    Sanofi-Aventis is recalling 51,325 vials of ADMELOG insulin lispro due to defective seals that may compromise sterility. Affected lot: 3F497B, expires 12-31-2025. Contact your pharmacist if you are using this product.

    Product
    ADMELOG — ADMELOG (INSULIN LISPRO)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0631-2023·2023-05-24

    Piperacillin and Tazobactam Injection Recalled for Sterility Assurance Failure

    Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0599-2023·2023-05-24

    Ampicillin and Sulbactam for Injection Recalled for Sterility Assurance Issue

    Astral SteriTech has recalled Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. The recall affects 6,127 bottles.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0587-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Sterility Assurance Defect

    Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.

    Product
    Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0645-2023·2023-05-24

    FDA Recall: VANComycin 750mg Injectable Lacks Sterility Assurance

    Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.

    Product
    VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0622-2023·2023-05-24

    Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue

    Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.

    Product
    Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0588-2023·2023-05-24

    Ampicillin for Injection Recalled for Lack of Sterility Assurance

    Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.

    Product
    Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0609-2023·2023-05-24

    Cefepime for Injection recalled due to sterility assurance failure

    Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.

    Product
    Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0605-2023·2023-05-24

    Cefepime for Injection Vials Recalled Over Sterility Concerns

    Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.

    Product
    Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled Over Sterility Assurance Failure

    The FDA is recalling 11,555 bottles of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The nationwide recall affects all lots within expiry.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0586-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Sterility Assurance Concerns

    Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.

    Product
    Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-085-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0584-2023·2023-05-24

    Ampicillin for Injection Recalled for Lack of Sterility Assurance

    Piramal Critical Care is recalling Ampicillin for Injection nationwide due to lack of sterility assurance. Approximately 8,925 bottles are affected.

    Product
    Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-224-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0640-2023·2023-05-24

    Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.

    Product
    VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0641-2023·2023-05-24

    Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns

    Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.

    Product
    VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0590-2023·2023-05-24

    Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0633-2023·2023-05-24

    Succinylcholine Injection recalled for lack of sterility assurance

    Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.

    Product
    Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0594-2023·2023-05-24

    Ampicillin and Sulbactam Injection Recalled for Sterility Assurance Failure

    Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. No illnesses have been reported.

    Product
    Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0582-2023·2023-05-24

    Ampicillin Injection Vials Recalled for Sterility Assurance Failure

    Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.

    Product
    Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-222-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0585-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Lack of Sterility Assurance

    Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.

    Product
    Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-084-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2023·2023-05-24

    FDA Recalls Apollo Care Norepinephrine Injections Due to Sterility Assurance Failure

    Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.

    Product
    Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0601-2023·2023-05-24

    Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect

    The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.

    Product
    Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0589-2023·2023-05-24

    Ampicillin Injection Recalled for Lack of Sterility Assurance

    Astral SteriTech has recalled approximately 7,214 bottles of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide within the United States.

    Product
    Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-088-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0642-2023·2023-05-24

    Vancomycin Injectable Solution Recalled Due to Lack of Sterility Assurance

    Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.

    Product
    VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-204-50
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0577-2023·2023-05-24

    Ketotifen Fumarate eye drops recalled due to manufacturing quality control deviations

    RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.

    Product
    Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0618-2023·2023-05-24

    Ceftriaxone for Injection Recalled for Lack of Sterility Assurance

    Xellia Pharmaceuticals is recalling 739,750 vials of Ceftriaxone for Injection, USP due to lack of assurance of sterility. All affected lots nationwide should not be used.

    Product
    Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0616-2023·2023-05-24

    Ceftriaxone Injectable Antibiotic Recalled Nationwide for Sterility Assurance Deficiency

    Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.

    Product
    Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-094-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0604-2023·2023-05-24

    Cefepime for Injection Recalled Due to Lack of Sterility Assurance

    Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.

    Product
    Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0576-2023·2023-05-24

    Lorazepam Injection Vials Recalled Due to Manufacturing Quality Control Failures

    RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection due to discontinuation of the manufacturer's quality control program. The product may not meet specified identity, strength, quality, and purity standards.

    Product
    LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0581-2023·2023-05-24

    Ampicillin for Injection Recalled Due to Lack of Sterility Assurance

    Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.

    Product
    Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0634-2023·2023-05-24

    Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

    Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.

    Product
    FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0888-2023·2023-05-24

    Wakame Seaweed Salad recalled for undeclared wheat allergen

    Origami Catering's Wakame Seaweed Salad is recalled because wheat is present but not declared in the allergen statement. Affected product: 4.5oz packages, UPC 8 51016 00235 5, distributed in Oregon and Washington.

    Product
    Wakame Seaweed Salad, ready to eat product. Net Weight: 4.5oz 127g. UPC 8 51016 00235 5. Label Ingredients declares: Seaweed (Wakame), Agar Agar ***, Sesame Seeds, Sesame Oil,***Soy Sauce ( Soy, Wheat***)*** Contains Soy, Sesame***". UPC: 8 51016 00235 5. Manufactured by Origam
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1608-2023·2023-05-24

    Beckman Coulter Bicarbonate Reagent Recalled for Calibration Failure Risk

    Beckman Coulter is recalling Bicarbonate reagent (REF: OS6637) due to potential calibration failures. The reagent could produce decreased optical density readings affecting laboratory quality control.

    Product
    Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2023·2023-05-24

    Dental implant system recalled for incorrect package length labeling

    Hiossen Inc. is recalling 287 units of ET III Nano-HA dental implants due to incorrect package labeling stating implant length as 10mm when the actual length is 8.5mm. No illnesses or injuries have been reported.

    Product
    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0647-2023·2023-05-24

    Vancomycin IV Injection Recalled for Lack of Sterility Assurance

    Apollo Care LLC is recalling VANComycin 1.5g IV injections because the manufacturer could not provide adequate assurance that batches met sterility standards. The recall affects 646 bags distributed in Missouri.

    Product
    VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1583-2023·2023-05-24

    Greiner Bio-One Blood Collection Tubes Recalled for Labeling Error

    Greiner Bio-One blood collection tubes (VACUETTE TUBE 6ml K3EDTA) may be incorrectly labeled. The company is recalling 36,000 units distributed in Wisconsin and Georgia.

    Product
    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2023·2023-05-24

    3M Attest Steam Chemical Integrators Recalled for Ink Leakage Risk

    3M is recalling 2.2 million Attest Steam Chemical Integrators (REF 1243B) due to an increased potential for ink leakage during sterilization cycles. No injuries have been reported.

    Product
    3M Attest Steam Chemical Integrators, REF 1243B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2023·2023-05-24

    Pyrazinamide 500 mg Tablets Recalled for Quality Program Discontinuation

    RemedyRepack Inc. is recalling Pyrazinamide 500 mg tablets because the original manufacturer discontinued the quality assurance program that would ensure the product meets identity, strength, quality, and purity standards.

    Product
    Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA 15701. Mfg NDC # 61748-0012-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1588-2023·2023-05-24

    Philips diagnostic imaging systems recalled for missing FDA certification labels

    Philips is recalling 25 CombiDiagnost R90 diagnostic systems nationwide due to missing required FDA certification labels. Affected healthcare facilities should contact Philips for instructions.

    Product
    CombiDiagnost R90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1587-2023·2023-05-24

    Diagnostic Imaging Systems Missing FDA Certification Label

    Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.

    Product
    ProxiDiagnost N90 R.1.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V361000·2023-05-22

    Polestar Recalls 2020-2021 Polestar 1 Vehicles Due to Battery Fire Risk

    Polestar is recalling 2020-2021 Polestar 1 vehicles because defective high-voltage battery cells may overheat and cause a fire. Dealers will replace the battery pack free of charge.

    Product
    POLESTAR — POLESTAR POLESTAR 1
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·018-2023·2023-05-19

    Sofina Recalls Mortadella Deli Meat Due to Undeclared Pistachio Allergen

    Sofina Foods is recalling ready-to-eat mortadella deli meat products because they may contain undeclared pistachios, a known allergen.

    Product
    Sofina Foods Inc. Recalls Ready-To-Eat Mortadella Deli Meat Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·23V359000·2023-05-19

    2023 Forest River Salem and Wildwood Travel Trailer Propane System Recall

    Forest River is recalling 2023 Salem and Wildwood travel trailers due to missing thread sealant on furnace fittings. The defect can cause propane gas leaks, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V354000·2023-05-18

    Tico Spotter B 6.7 Trucks Recalled for Steering Gear Fracture Risk

    Terminal Investment Corporation is recalling 2022-2023 Tico Spotter B 6.7 trucks because incorrectly assembled steering gears may fracture, causing loss of steering control.

    Product
    TICO — TICO SPOTTER B 6.7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23207·2023-05-18

    BQQZHZ Combination Smoke and Carbon Monoxide Detectors May Fail to Alert

    The CPSC is warning consumers to stop using BQQZHZ combination smoke and carbon monoxide detectors immediately because they can fail to alert to hazardous smoke and fire. About 25,000 units sold on Amazon.com are affected.

    Product
    BQQZHZ Combination Smoke and Carbon Monoxide Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23205·2023-05-18

    PowerXL Stuffed Wafflizer Waffle Makers Recalled for Burn Hazard

    About 456,000 PowerXL Stuffed Wafflizer waffle makers are being recalled because hot pieces of waffle or stuffing can be expelled during use or when opening the product, creating a burn risk. The firm has received 44 incident reports, including 34 burn injuries with three requiring medical attention.

    Product
    PowerXL Stuffed Wafflizer waffle makers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23204·2023-05-18

    Target Recalls 4.9 Million Threshold Glass Jar Candles for Laceration and Burn Risk

    Target is recalling approximately 4.9 million Threshold Glass Jar Candles because the glass jar can crack or break during use, posing laceration and burn hazards. Six injuries, including lacerations and severe burns, have been reported.

    Product
    Threshold Glass Jar Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·23760·2023-05-18

    Polaris RZR Pro XP and Turbo R vehicles recalled due to fuel leak fire hazard

    Polaris is recalling about 20,330 Model Year 2021–2023 RZR Pro XP 4 and Model Year 2022–2023 RZR Turbo R 4 recreational off-road vehicles because a fuel leak at the fuel pump assembly can occur near a hot surface, posing a fire hazard. The company has received five reports of fuel leaks, including one report of fire.

    Product
    Model Year 2021-2023 RZR Pro XP 4 and Model Year 2022-2023 RZR Turbo R 4 vehicles Recreational Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V351000·2023-05-18

    Fleetwood, Holiday Rambler Motorhomes Recalled for Damaged Trailer Hitch

    REV Recreation Group is recalling 2020-2024 Fleetwood Bounder, Holiday Rambler Vacationer, and select Fleetwood Southwind motorhomes. The trailer hitch may become damaged due to stress or overloading, potentially causing the towed vehicle to separate.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER, BOUNDER, SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23203·2023-05-18

    PhysiciansCare Allergy and Cold and Cough Tablets Lack Child-Resistant Packaging

    Acme United is recalling PhysiciansCare Allergy, Allergy Plus, and Cold and Cough tablets sold on Amazon.com from January 2021 through August 2022 because the packaging is not child resistant, risking poisoning if young children swallow the contents.

    Product
    PhysiciansCare Allergy, Allergy Plus and Cold and Cough
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·23759·2023-05-18

    Ventura Adult Bike Helmets Recalled for Risk of Head Injury

    Messingschlager USA LLC (Cycle Force) is recalling about 1,750 Ventura Adult Bike Helmets because they do not meet federal safety standards for positional stability and can fail to protect in a crash. No injuries have been reported.

    Product
    Ventura Adult Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V358000·2023-05-18

    2021-2023 Ford Bronco Seat Belt Latch Accessibility Recall

    Ford is recalling certain 2021-2023 Bronco vehicles because first-row seat belt latch plates may be difficult to access, potentially preventing occupants from wearing their seat belts and increasing crash injury risk.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V357000·2023-05-18

    Altec Aerial Devices Recalled for Water Intrusion Fire Risk

    Altec is recalling 2021-2023 aerial devices, digger derricks, and related equipment because water can leak into strobe lights, causing electrical short-circuits that increase fire risk. No injuries have been reported.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK, EFFER CRANE, SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V356000·2023-05-18

    Gillig Recalls 2022 Low Floor Buses Due to Electrical Fire Risk

    Gillig is recalling 2022 Low Floor CNG transit buses because an electrical failure in the fuse box may cause a short-circuit, increasing the risk of a fire.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V353000·2023-05-18

    Navistar International trucks recalled for inadequate back-up light visibility

    Navistar is recalling certain International trucks (2000-2024 model years) for inadequate back-up light visibility when reversing. Low visibility may not alert other drivers, increasing crash risk. Dealers will replace rear stop/turn signal lights free of charge.

    Product
    INTERNATIONAL — INTERNATIONAL MV, 9400I, 9100I, 9200I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V355000·2023-05-18

    VinFast Recalls 2023 VF 8 Vehicles Due to Display Software Error

    VinFast is recalling 2023 VF 8 vehicles because a software error may cause the main display to go blank, hiding critical safety information like the speedometer.

    Product
    VINFAST — VINFAST VF 8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V352000·2023-05-18

    Jeep Grand Cherokee Steering Column Intermediate Shaft Defect Recall

    Certain 2021–2023 Jeep Grand Cherokee models have an incorrectly assembled steering column intermediate shaft that may disconnect and cause loss of steering control, increasing crash risk. Chrysler is offering free inspection and replacement.

    Product
    JEEP — JEEP GRAND CHEROKEE 4XE, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2023.