The Recall Desk

Archive

June 2024 recalls

526 recalls were announced in June 2024.

What the numbers show

Critical
17
Severe
130
High
341
Moderate
34
Low
4

Of the 526 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

401–500 of 526

  • HighNHTSA·24E047000·2024-06-06

    Chrysler Recalls MOPAR ABS Control Modules for Software Malfunction

    Chrysler is recalling MOPAR anti-lock braking system control modules used as replacement parts in 2022 Dodge Durango and Ram 2500/3500 vehicles. A software malfunction may disable electronic stability control, increasing crash risk.

    Product
    SERVICE BRAKES, AIR:ANTILOCK:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24258·2024-06-06

    Sling Carriers Recalled for Infant Suffocation and Fall Hazards

    About 1,160 sling carriers sold on Walmart.com through Joybuy Marketplace Express are recalled due to violations of federal safety standards. The carriers pose suffocation and fall hazards to infants because they lack required structural integrity, occupant retention, and proper restraint systems.

    Product
    Sling Carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24257·2024-06-06

    FURminator deShedding Dog Conditioner Recalled for Bacterial Contamination

    Spectrum Brands is recalling about 102,000 units of FURminator deShedding Ultra Premium Dog Conditioner (1 Gallon) because the product can contain Pseudomonas aeruginosa bacteria, which poses a serious infection risk to people with weakened immune systems or external medical devices.

    Product
    FURminator deShedding Ultra Premium Dog Conditioner (1 Gallon)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V414000·2024-06-06

    2024 Jeep Wrangler Recalled for Trailer Lighting Malfunction

    Chrysler is recalling 2024 Jeep Wrangler vehicles because the power distribution center may prevent trailer turn signals and taillights from operating, increasing crash risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V419000·2024-06-06

    2022-2024 Toyota Highlander Tires Recalled Due to Insufficient Load Rating

    Gulf States Toyota is recalling 2022-2024 Toyota Highlander L and Highlander LE vehicles with the Blackout Package because their installed tires have insufficient load rating and may fail, increasing crash risk.

    Product
    TOYOTA — TOYOTA HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V415000·2024-06-06

    2022 RAM 2500 Electronic Stability Control Software Defect

    Chrysler is recalling 2022 RAM 2500 and 3500 vehicles due to an ABS control module software malfunction that can disable the electronic stability control system, increasing crash risk. Dealers will provide a free software update.

    Product
    RAM — RAM, DODGE 2500, DURANGO, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V416000·2024-06-06

    RAM ProMaster vehicles recalled for missing side door beam and incorrect seating label

    Certain 2021-2024 RAM ProMaster vehicles lack a side door beam and have incorrect seating capacity information on the tire placard. These defects may reduce occupant protection in side-impact crashes and could result in improper vehicle loading.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V406000·2024-06-06

    North Central Emergency Recalls 2021 Ford E-450 for Electrical Fire Risk

    North Central Emergency is recalling one 2021 Ford E-450 because a firmware defect in Weldon nodes may cause electrical circuits to overheat and catch fire.

    Product
    NORTH CENTRAL EMERGENCY — NORTH CENTRAL EMERGENCY FORD E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V413000·2024-06-06

    2023 RAM 1500, 2500, 3500 Transmission Control Unit Weld Defect

    Chrysler recalls 2023 RAM 1500, 2500, and 3500 vehicles with a transmission control unit weld defect that may cause transmission fluid to leak onto electrical components, resulting in loss of drive power or park function.

    Product
    RAM — RAM 3500, 2500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24255·2024-06-06

    Biometric Firearm Safes Recalled for Unauthorized Access Risk

    SA Consumer Products is recalling Sanctuary Quick Access and Sports Afield Biometric Firearm Safes because the biometric lock can be opened by unauthorized users, posing a serious injury hazard and risk of death. No injuries have been reported.

    Product
    Sanctuary and Sports Afield Biometric Firearm Safes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24259·2024-06-06

    Wild Country Ropeman 1 Ascenders Recalled for Failure to Engage

    Salewa USA recalls Wild Country Ropeman 1 ascenders because the teeth can fail to engage, making it difficult or impossible to ascend. About 7,700 units sold in the United States since December 2022.

    Product
    Wild Country Ropeman 1 ascenders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1274-2024·2024-06-05

    Gibson Farms Organic Nuts Recalled for Potential E. Coli Contamination

    Gibson Farms Organic Nuts – Light Halves and Pieces are recalled due to potential E. coli O157:H7 contamination. Affected lots 3325-043 and 3341-501 were distributed to California and Washington.

    Product
    Gibson Farms Organic Nuts -Light Halves and Pieces
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24V411000·2024-06-05

    Vermeer Recalls 2023 Vacuum Excavator Trailers Due to Frame Defect

    Vermeer is recalling 2023 LPSDT vacuum excavator trailers because the frame may bend or distort, potentially causing loss of stability and control while towing.

    Product
    VERMEER — VERMEER VACUUM EXCAVATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V407000·2024-06-05

    2023 Kia Telluride power seat motor fire risk recall

    Kia is recalling certain 2023 Telluride vehicles due to a fire risk in the front power seat motor caused by a stuck seat slide knob. Owners should park outside until repairs are completed.

    Product
    KIA — KIA TELLURIDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2024·2024-06-05

    Medline Sub-G Endotracheal Tubes with Subglottic Suctioning—Inflation and Suction Defects

    Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.

    Product
    Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0511-2024·2024-06-05

    Compounded Tirzepatide Vials Mislabeled with Testosterone Cypionate

    Revive Rx Pharmacy recalls 751 vials of compounded tirzepatide (Lot #748127) labeled to contain tirzepatide but actually filled with testosterone cypionate. Patients receiving this medication may take the wrong drug with serious health consequences.

    Product
    Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V408000·2024-06-05

    Rivian R1S and R1T damaged pillar clips affect airbag deployment

    Rivian is recalling certain 2022-2024 R1S and R1T vehicles. Damaged attachment clips on pillar trim panels may prevent proper side curtain airbag deployment in a crash, increasing injury risk.

    Product
    RIVIAN — RIVIAN R1T, R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V412000·2024-06-05

    2024 Hyundai Tucson and Santa Cruz power steering defect recall

    Hyundai is recalling 2024 Tucson and Santa Cruz vehicles due to a potential circuit board short in the power steering system. Loss of steering assist could increase crash risk.

    Product
    HYUNDAI — HYUNDAI TUCSON, SANTA CRUZ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1304-2024·2024-06-05

    Hy-Vee cookies and cream mix products recalled due to Salmonella

    Hy-Vee Stores Inc is recalling Hy-Vee To Go and Hy-Vee Cookies & Cream Mix products due to potential Salmonella contamination. Affected products were distributed in eight Midwest states.

    Product
    Hy-Vee To Go Cookies & Cream Mix, Net wt. 4 oz (113g), UPC 0075450486740, 6 containers per case. Hy-Vee Cookies & Cream Mix, Net Wt. 16oz (453g), UPC 0075450486730, 6 containers per case.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Drugs)·D-0514-2024·2024-06-05

    Intraocular injection drug recalled due to sterility assurance failure

    Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots were distributed nationwide.

    Product
    Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0515-2024·2024-06-05

    Moxifloxacin intraocular injection vials recalled for sterility assurance failure

    Imprimis NJOF, LLC recalls Moxifloxacin intraocular injection vials nationwide due to lack of sterility assurance. The 18,980 affected vials (lot 23OCT013) should not be used.

    Product
    Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2024·2024-06-05

    Ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.

    Product
    20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2024·2024-06-05

    Medline medical procedure kits recalled for potential needle guide ring detachment

    Medline is recalling 12,994 paracervical and pudendal procedure kits because the Trumpet Needle Guide ring can detach when excessive pressure is applied, potentially causing injury.

    Product
    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure conve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2024·2024-06-05

    Centurion OB Instrument Tray Recalled for Detachable Needle Guide Component

    Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical procedures.

    Product
    Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1266-2024·2024-06-05

    Ganache chocolate boxes recalled for undeclared coconut allergen

    Maribel's Sweets, Inc. is recalling 2pc signature Ganache boxes nationwide due to undeclared coconut allergen. Consumers with coconut allergies should not consume this product.

    Product
    2. 2pc signature Ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2024·2024-06-05

    Mako 3.0 and 3.1 surgical systems software error causes treatment delays

    Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1280-2024·2024-06-05

    H-E-B Ice Cream Recalled for Potential Metal Contamination

    H-E-B Creamy Creations ice cream in 12-packs is being recalled due to potential metal contamination. Affected products have code dates from August 31 to September 3, 2024, and were distributed in Texas.

    Product
    3-ounce H-E-B Creamy Creations Ice Cream Lime/Orange Combo - 12 pack
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1919-2024·2024-06-05

    Dako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage

    Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.

    Product
    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0526-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Ingredients

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1267-2024·2024-06-05

    Ganache candy boxes recalled nationwide for undeclared coconut allergen

    Maribel's Sweets is recalling 4,011 boxes of 4-piece ganache candy because they contain undeclared coconut, which poses an allergen risk to consumers with coconut allergies.

    Product
    3. 4pc ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2024·2024-06-05

    Mako Robotic Surgery Software Error May Delay Orthopedic Treatments

    Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1929-2024·2024-06-05

    BD Pyxis MedStation ES 7-Drawer Auxiliary Tower Recalled for Fire Risk

    CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2024·2024-06-05

    Stryker neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.

    Product
    Trevo ProVue, Catalog: 90184
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1277-2024·2024-06-05

    Texas Pecan Co Mixed Nuts Recalled for Potential Allergen Cross-Contamination

    Texas Pecan Co is recalling mixed nut and dried fruit products due to potential cross-contamination with milk, soy, sesame, wheat, tree nuts, and peanuts. Consumers with allergies should not consume the affected products.

    Product
    1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds, Natural Sliced Almonds, Blanched Slivered Almonds, Blanched Whole Almonds and
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·24V403000·2024-06-05

    Timpte Recalls 2024-2025 Deck Trailers Due to Ramp Bolt Defect

    Timpte is recalling 2024-2025 1420 and 1424 deck trailers because retaining rod bolts may fall off, leaving the folding ramp unsecured and increasing injury risk.

    Product
    TIMPTE — TIMPTE TIMPTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V405000·2024-06-05

    2023 Fisker Ocean Recall: Instrument Cluster Warning Lights Display Incorrectly

    Fisker is recalling 2023 Ocean vehicles because warning lights display with incorrect font sizes and colors, and fail to illuminate during bulb checks. The defect risks drivers missing critical safety information.

    Product
    FISKER — FISKER OCEAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1268-2024·2024-06-05

    Maribel's Sweets 6-piece ganache boxes recalled for undeclared coconut

    Maribel's Sweets, Inc. is recalling 4,011 boxes of 6-piece signature ganache chocolate boxes due to undeclared coconut. Consumers with coconut allergies are at risk.

    Product
    4. 6pc signature ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2024·2024-06-05

    FlowGate2 neurovascular devices may exceed endotoxin limits due to inadequate testing

    Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.

    Product
    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2024·2024-06-05

    Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements

    Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper system restart.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0516-2024·2024-06-05

    Moxifloxacin Intraocular Injection Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.

    Product
    Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V410000·2024-06-05

    Wabash National Refrigerated Van Trailers Recalled for Base Rail Detachment Risk

    Wabash National Corporation is recalling certain 2024-2025 refrigerated van trailers because the base rails may not be bonded properly and can detach, reducing structural strength and increasing crash risk.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V404000·2024-06-05

    2023 Fisker Ocean Software Defect Causes Loss of Drive Power

    Fisker is recalling all 2023 Ocean vehicles. A software defect in the MCU/VCU can cause unexpected loss of drive power, increasing crash risk.

    Product
    FISKER — FISKER OCEAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2024·2024-06-05

    EsophaCap esophageal diagnostic sponge recalled for detachment risk

    Lucid Diagnostics recalls EsophaCap esophageal diagnostic sponges due to risk of sponge detachment from string during device removal. No injuries have been reported.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0521-2024·2024-06-05

    Pain Relieving Cream Recalled Due to Out-of-Specification Active Ingredient

    ARG Laboratories' Natural Pain Relieving Cream Golden Tiger is being recalled due to out-of-specification active ingredient and improper-grade propylene glycol used in manufacturing. No illnesses have been reported.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2024·2024-06-05

    Vercise Genus Deep Brain Stimulation Device May Reset During Charging

    Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.

    Product
    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0530-2024·2024-06-05

    ALOE GATOR SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0520-2024·2024-06-05

    Pain Wizard Topical Pain Relief Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0513-2024·2024-06-05

    Intraocular Injection Recalled for Sterility Assurance Failure

    Imprimis NJOF, LLC is recalling preservative-free intraocular injection vials of Dexamethasone-Moxifloxacin due to lack of assurance of sterility. Approximately 39,700 vials were distributed nationwide.

    Product
    Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1925-2024·2024-06-05

    Ophthalmic surgical knives recalled due to sharpness complaints

    Alcon is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel) due to increased reports of sharpness issues. The recall affects 4,930 units distributed worldwide.

    Product
    ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2024·2024-06-05

    Tri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling

    Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.

    Product
    Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2024·2024-06-05

    Surgical screwdrivers recalled for failure to engage with implant screws

    Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.

    Product
    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0512-2024·2024-06-05

    Epinephrine-Lidocaine Intraocular Injection Vials Recalled for Sterility Assurance

    Imprimis NJOF, LLC is recalling 14,180 vials of Epinephrine-Lidocaine intraocular injection due to lack of assurance of sterility. These vials were distributed nationwide within the United States.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0522-2024·2024-06-05

    Bull Frog SPF 50 Sunscreen Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Bull Frog SPF 50 Amphibious Lotion nationwide due to the active ingredient being out of specification. Consumers with affected lots should not use the product and contact the manufacturer.

    Product
    Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0510-2024·2024-06-05

    Zoledronic Acid Injection Recalled for Sterility Defect

    Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1924-2024·2024-06-05

    Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects

    Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.

    Product
    ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2024·2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2024·2024-06-05

    Mirion Captus 4000e Thyroid Uptake System Recalled for Collimator Detachment

    Mirion Technologies is recalling the Captus 4000e Thyroid Uptake System due to complaints of unexpected collimator detachment. Affected users should contact the manufacturer for guidance.

    Product
    Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2024·2024-06-05

    Neurovascular devices recalled due to inadequate endotoxin testing

    Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.

    Product
    DAC 044 115cm, Catalog: 90760
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0525-2024·2024-06-05

    Pain Wizard topical pain relief recalled for manufacturing specification violation

    ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1269-2024·2024-06-05

    9-Piece Signature Box Recalled for Undeclared Coconut

    Maribel's Sweets 9-piece signature boxes are recalled nationwide due to undeclared coconut. Consumers with coconut allergies should not consume this product.

    Product
    5. 9pc signature box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1278-2024·2024-06-05

    Texas Pecan Co Mixed Nuts and Dried Fruits Recall for Allergen Cross-Contamination

    Texas Pecan Co is recalling mixed nuts and dried fruits due to potential cross-contamination with allergens including milk, soy, sesame, and wheat. Consumers with allergies to these allergens should not consume the affected products.

    Product
    1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds, Natural Sliced Almonds, Blanched Slivered Almonds, Blanched Whole Almonds and
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1279-2024·2024-06-05

    H-E-B Ice Cream Recalled for Potential Metal Contamination

    H-E-B Creamy Creations Ice Cream is being recalled due to potential metal contamination. The 3-ounce 12-packs distributed in Texas with code dates 09/11/2024 through 09/21/2024 may be affected.

    Product
    3-ounce H-E-B Creamy Creations Ice Cream Homemade/Chocolate Combo -12 pack
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1901-2024·2024-06-05

    Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch

    Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.

    Product
    smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1271-2024·2024-06-05

    Mother's Day Heart Box Recalled for Undeclared Coconut Allergen

    Maribel's Sweets, Inc. is recalling its 7.7-piece Mother's Day heart box due to undeclared coconut. The product may pose a risk to consumers with coconut allergies. Approximately 4,011 boxes were distributed nationwide and through online retailers.

    Product
    7. 7pc Mother s Day heart box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1265-2024·2024-06-05

    Ganache tote boxes recalled for undeclared coconut allergen

    Maribel's Sweets, Inc. is recalling 4,011 ganache tote boxes containing undeclared coconut. The product was distributed nationwide through e-commerce and retail stores in New York.

    Product
    1. 2pc Ganache tote box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1283-2024·2024-06-05

    Veggies Made Great Frozen Breakfast Potato Bakes Recalled for Possible Listeria

    Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes are being recalled due to possible Listeria monocytogenes contamination. The frozen product was distributed to multiple western U.S. states.

    Product
    Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes. Net Wt. 36 OZ (2.25 LB) 1.02 KG. UPC: 70486300103. Frozen product. Individually wrapped in flowrap, 18 bakes per box.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1276-2024·2024-06-05

    Fresh N Lean Crustless Chicken Potato Pot Pie Recalled for Possible Listeria Contamination

    Nutrition Corp is recalling Fresh N Lean Crustless Chicken Potato Pot Pie due to possible Listeria monocytogenes contamination. The affected product was distributed nationwide with an expiration date of 5/08/2024.

    Product
    Fresh N Lean brand Crustless Chicken Potato Pot Pie. Packaged in plastic trays, vacuum sealed.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1273-2024·2024-06-05

    Mother's Day Heart Ganache Boxes Recalled for Undeclared Coconut

    Maribel's Sweets, Inc. is recalling Mother's Day heart ganache boxes because they contain undeclared coconut, an allergen not listed on the label. This poses a risk to consumers with tree nut allergies.

    Product
    9. 25pc Mother s Day heart ganache box
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1281-2024·2024-06-05

    H-E-B Chocolate Ice Cream recalled for potential metal contamination

    H-E-B Creamy Creations Chocolate Ice Cream 3-ounce 12-packs distributed in Texas are recalled due to potential metal contamination. Consumers should not consume the affected product.

    Product
    3-ounce H-E-B Creamy Creations Chocolate Ice Cream-12 pk
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0509-2024·2024-06-05

    Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers

    Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.

    Product
    CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0531-2024·2024-06-05

    EYLEA injectable eye medication recalled due to sterility and syringe breakage

    Regeneron is recalling 405,725 prefilled syringes of EYLEA (aflibercept) eye injection due to lack of assurance of sterility and complaints of syringe breakage. This FDA Class II recall affects multiple lots distributed nationwide.

    Product
    EYLEA — EYLEA (AFLIBERCEPT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0518-2024·2024-06-05

    Cefdinir Oral Suspension recalled nationwide for defective container seals

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0517-2024·2024-06-05

    Metoprolol Tartrate Tablets Recalled Nationwide for Metal Contamination

    Rubicon Research is recalling 11,664 bottles of Metoprolol Tartrate 25mg tablets nationwide due to the presence of metal in the tablets. Consumers should discontinue use and contact their healthcare provider.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0529-2024·2024-06-05

    Golden Tiger Pain Relief Cream Recalled for Out-of-Specification Active Ingredient

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to the active ingredient being out of specification and improper grade propylene glycol being used during manufacturing.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0519-2024·2024-06-05

    FDA Recalls Epinephrine-Lidocaine Intraocular Injections Due to Sterility Concerns

    Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2024·2024-06-05

    Philips Allura Xper FD10 system pivot brake failure after software update

    Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2024·2024-06-05

    Philips Hemodynamic Application software pressure wave data synchronization defect

    Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.

    Product
    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2024·2024-06-05

    FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment

    The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.

    Product
    Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2024·2024-06-05

    BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk

    CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" Anesthesia Station ES, REF: 327
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2024·2024-06-05

    Radiographic imaging system tubes may fall due to bolt rupture

    FUJIFILM's FDR Visionary Suite radiographic imaging system has bolts that may rupture due to fatigue, potentially causing the tube support to fall and injure patients. The recall affects 18 units distributed across nine states.

    Product
    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2024·2024-06-05

    Captus 4000e Thyroid Uptake System recalled for unexpected collimator detachment

    Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.

    Product
    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2024·2024-06-05

    Synchro Guide Wires Recalled for Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.

    Product
    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2024·2024-06-05

    Trevo NXT neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.

    Product
    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2024·2024-06-05

    BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

    BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

    Product
    BD Pyxis MedStation ES, REF: 323, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2024·2024-06-05

    BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

    The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2024·2024-06-05

    Philips Allura Xper FD20 patient table brake may fail to engage after software update

    Philips Allura Xper FD20 X-ray systems with ADN7NT patient tables may have a pivot brake failure after software upgrade 8.1.100 is installed. This could cause unexpected table movements during use.

    Product
    Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1902-2024·2024-06-05

    Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing

    Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.

    Product
    Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2024·2024-06-05

    Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination

    Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.

    Product
    Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2024·2024-06-05

    RefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error

    Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1900-2024·2024-06-05

    EsophaCap Sponge May Detach From String During Removal

    Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2024·2024-06-05

    BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

    CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.

    Product
    BD Pyxis(TM) Anesthesia Station 4000, REF: 338
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2024·2024-06-05

    Philips Allura Xper FD20 Software Update Disables Pivot Brake on Patient Table

    A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0527-2024·2024-06-05

    Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2024·2024-06-05

    Stryker Mako Surgical Robot Software Error Causes Treatment Delays

    Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
    Category
    Medical Device
    Distribution
    Distributed nationwide

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