The Recall Desk

Archive

February 2025 recalls

506 recalls were announced in February 2025.

What the numbers show

Critical
7
Severe
122
High
357
Moderate
20

Of the 506 recalls this month scored against our rubric, 1% are Critical, 24% are Severe.

401–500 of 506

  • SevereCPSC·25126·2025-02-06

    LG Recalls Electric Ranges Over Fire Hazard From Accidental Knob Activation

    LG is recalling about 500,000 electric ranges because front-mounted knobs can be accidentally activated by people or pets, creating a fire hazard. The company has received three reports of fires causing smoke and property damage.

    Product
    Slide-In and Freestanding Electric Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25125·2025-02-06

    Jazwares Recalls America's Got Talent Microphones Due to Battery Fire Hazard

    Jazwares recalls about 125,000 America's Got Talent microphones whose lithium-ion batteries can overcharge and ignite. Three incidents with fire damage have been reported, but no injuries.

    Product
    America's Got Talent microphones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25127·2025-02-06

    RYOBI Cordless Walk-Behind Mowers Recalled for Connector Fire Hazard

    RYOBI 40-Volt cordless walk-behind mowers are being recalled due to a push-on connector that can overheat and cause fires. The manufacturer has received 97 reports of overheating, 5 reports of fires, and 2 minor burn injuries.

    Product
    RYOBI 40-Volt Brushless 21" Cordless Walk-Behind Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V057000·2025-02-06

    Hino Recalls 2022-2025 Trucks Due to Brake Tube Leak Risk

    Hino is recalling 2022-2025 trucks because contact with the fender can damage the front right brake tube, causing leaks that increase stopping distance.

    Product
    HINO — HINO NV7B, NV7A, NH7A, NJ7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V060000·2025-02-06

    2022 GMC Sierra 1500 front grille deflectors may detach

    General Motors is recalling certain 2022 GMC Sierra 1500 vehicles with chrome front grille deflectors because attachment points may fracture, causing the grille to detach and become a road hazard.

    Product
    GMC — GMC SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V059000·2025-02-06

    2025 Lexus NX vehicles recalled for damaged rear seat belt webbing

    Toyota is recalling certain 2025 Lexus NX and other vehicles because the second-row center seat belt webbing may be damaged, potentially reducing occupant restraint in a crash.

    Product
    LEXUS — LEXUS, TOYOTA NX, RX, NX HYBRID, RX HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V064000·2025-02-06

    2025 Hyundai Ioniq 5 rear side air bag deployment failure recall

    Hyundai is recalling certain 2025 Ioniq 5 electric vehicles because the rear floor wiring harness may contain an open circuit, preventing the rear side air bag from deploying as intended and increasing injury risk in a crash.

    Product
    HYUNDAI — HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25122·2025-02-06

    UVIPC Baby Gates Recalled for Entrapment Hazard Violation

    UVIPC Baby Gates sold on Amazon have been recalled due to an entrapment hazard that violates federal safety regulations, as children's torsos can fit through gaps in the gate design. No injuries have been reported.

    Product
    UVIPC Baby Gates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25123·2025-02-06

    Sling Carriers Recalled for Fall Hazard Due to Safety Violations

    About 18,650 sling carriers sold on Temu.com violate federal safety regulations for structural integrity and occupant retention, posing a fall hazard to babies. No injuries have been reported.

    Product
    Sling Carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V058000·2025-02-06

    2025 Toyota Tacoma Rear Brake Hoses Subject to Fluid Leak Risk

    Toyota is recalling certain 2024–2025 Tacoma 4-wheel drive vehicles because rear brake hoses can be damaged by mud and dirt buildup, causing brake fluid leaks that reduce braking ability and increase crash risk.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V065000·2025-02-06

    2025 Hyundai IONIQ 5 Left-Foot Braking Software Defect Recall

    Hyundai is recalling certain 2025 IONIQ 5 "N" vehicles with left-foot braking because a software defect in the electronic brake and vehicle control systems may reduce braking performance, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI IONIQ 5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25E009000·2025-02-06

    Firefly Integrations Recalls Thor Motor Coach G12 Electronic Control Modules

    Firefly Integrations is recalling specific G12 Electronic Control Modules installed in Thor Motor Coach vehicles due to a software error that may allow the awning to extend while driving.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25121·2025-02-06

    Bobcat and Steiner AirFX Finish Mower Deck Attachments Recalled for Crush Hazard

    Doosan Bobcat is recalling about 552 AirFX Finish Mower Deck attachments because the locking pins may fail to secure the deck during maintenance, creating a crush hazard. No injuries have been reported.

    Product
    Bobcat & Steiner AirFX Finish Mower Deck attachments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25124·2025-02-06

    Ariens Snow Throwers Recalled Due to Laceration Hazard from Continued Rotation

    Ariens snow throwers may continue rotating after the operator releases the control lever, creating a laceration hazard. The company is offering free repairs at authorized dealers.

    Product
    Ariens® DELUXE-, PLATINUM- and PROFESSIONAL-series Snow Throwers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25120·2025-02-06

    Pella Sliding Patio Doors and Windows Recalled for Battery Ingestion Hazard

    Pella Corporation is recalling about 340 Pella Reserve and Lifestyle sliding patio doors and windows because their sensor panels and remote controls contain button cell batteries that children can easily access, posing an ingestion hazard.

    Product
    Pella Reserve and Lifestyle Sliding Patio Doors and Lifestyle Windows
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25128·2025-02-06

    Roll-Up Window Blinds Recalled for Child Strangulation and Entanglement Hazards

    Thy Trading Company recalls approximately 720 roll-up window blinds sold on Wayfair.com due to long operating cords that pose strangulation and entanglement hazards to children. Consumers should stop using the blinds immediately and request a full refund.

    Product
    Roll Up Window Blinds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25118·2025-02-06

    TravisMathew Hoodies and Sweatshirts Recalled for Flammability Violation and Burn Hazard

    TravisMathew recalled approximately 59,450 women's and men's hoodies and sweatshirts sold from January through October 2024 due to violation of federal flammability standards, posing a burn hazard.

    Product
    TravisMathew Women's Sweatshirts and Women's and Men's Hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0454-2025·2025-02-05

    Sushi Rolls Recalled Due to Possible Salmonella Contamination

    GBC Food Services (Yummi Sushi) has recalled multiple sushi roll products due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.

    Product
    Vegetarian Roll UPC: 85375900869 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Vegetarian Roll (Brown Rice) UPC: 85694200824 Qty: 1 Tray, Net Wt: 6.1oz (174g) 11/22 to 11/29/2024 Mixed Vegetable Roll (Brown Rice) UPC: 85694200880 Net Wt: 7.1oz (202g) 11/22 to 11/29/2024 V
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0211-2025·2025-02-05

    Prograf Tacrolimus Capsules Recall: Empty Capsules in Bottles

    Astellas Pharma recalls Prograf (tacrolimus) 0.5 mg capsules distributed nationwide due to empty capsules in bottles. Affected lot 0E3353D expires March 31, 2026.

    Product
    PROGRAF — PROGRAF (TACROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0428-2025·2025-02-05

    Lay's Classic Potato Chips recalled for undeclared milk allergen

    Frito Lay Inc. is recalling 6,344 bags of 13 oz. Lay's Classic Potato Chips distributed in Washington and Oregon due to an undeclared milk allergen that could cause allergic reactions.

    Product
    13 oz. Lay's Classic Potato Chips.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0449-2025·2025-02-05

    Sushi rolls recalled for possible Salmonella contamination in Texas

    GBC Food Services has recalled multiple sushi products due to possible Salmonella contamination. The affected products were distributed in Texas with best-by dates through 11/30/2024.

    Product
    California Roll (Crab Salad) UPC: 85375900857 Qty: 1 Tray, Net Wt: 7.6oz (216g) 11/22 to 11/29/2024. California Roll (Crab Stick) UPC: 85375900858 Qty: 1 Tray, Net Wt: 7.6oz (216g) 11/22 to 11/29/2024 Volcano Roll UPC: 85375900886 Qty: 1 Tray, Net Wt: 10.8oz (305g) 11/22 to 11/29
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·25E007000·2025-02-05

    Samsung SDI Recalls High-Voltage Battery Packs for Multiple Vehicle Brands

    Samsung SDI is recalling high-voltage battery packs installed in Chrysler, Volkswagen/Audi, and Ford vehicles because they may fail, increasing the risk of a crash or fire.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0445-2025·2025-02-05

    Vegetable Ranch Tray recalled for potential Salmonella contamination

    Vegetable Ranch Tray products from Yummi Sushi may contain Salmonella. Consumers who purchased items between November 22-29, 2024 should not eat them and should discard or return them.

    Product
    Vegetable Ranch Tray No Dip Small 850054894335 19.5 oz (553g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0443-2025·2025-02-05

    Individual Garden Salad Recalled for Potential Salmonella Contamination

    GBC Food Services (Yummi Sushi) is recalling 6,088 units of Individual Garden Salad due to potential Salmonella. Products purchased November 22-29, 2024, in Colorado are affected.

    Product
    Individual Garden Salad 850054894618 12 oz (340g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0437-2025·2025-02-05

    Cucumber slices with Tajin recalled for potential Salmonella contamination

    GBC Food Services is recalling 6,088 units of Cucumber Slices W/Tajin (10 oz, UPC 850053685699) due to potential Salmonella contamination. Products purchased November 22-29, 2024, distributed in Colorado are affected.

    Product
    Cucumber Slices W/Tajin 850053685699 10 oz (284g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0430-2025·2025-02-05

    Tzatziki Sauce Recalled Due to Potential Salmonella Contamination

    Corfu and Mediterranean brand tzatziki sauce in half-gallon tubs and 5-gallon pails are being recalled for potential Salmonella contamination. Consumers should not eat the affected products.

    Product
    Corfu Tzatziki sauce packaged in half gallon plastic tubs, 4 tubs per case. Mediterranean Tzatziki sauce packaged in half gallon plastic tubs, 4 tubs per case. Unbranded Tzatziki sauce packaged in half gallon plastic containers, 4 tubs per case. Corfu Tzatziki sauce packaged in 5
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0992-2025·2025-02-05

    Medline General Surgery Arterial Line Tray kits recalled for manufacturing defect

    Medline arterial line tray kits (models ART600 and ART690) are being recalled because the catheter hub contains excess material from manufacturing. The recall affects 58 kits distributed nationwide.

    Product
    Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0435-2025·2025-02-05

    Food Recall: Large Vegetable Tray Due to Potential Salmonella

    GBC Food Services recalls a Large Vegetable Tray due to potential Salmonella contamination. Consumers who purchased this product between November 22-29, 2024, should not consume it.

    Product
    Large Vegetable Tray 850054894571 42 oz (1190g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0442-2025·2025-02-05

    Ready-to-Eat Salad Recalled Due to Potential Salmonella Contamination

    GBC Food Services is recalling Individual Greek Salads with purchase dates between November 22-29, 2024, due to potential Salmonella contamination. The recall affects 6,088 units distributed in Colorado.

    Product
    Individual Greek Salad 850054894649 12 oz (340g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0438-2025·2025-02-05

    Yummi Sushi Cucumber Ranch Snack Cups Recalled for Salmonella Contamination

    GBC Food Services, LLC (Yummi Sushi) recalled Cucumber with Ranch Snack Cups due to potential Salmonella contamination. The recall affected 6,088 units distributed in Colorado with purchase dates of November 22–29, 2024.

    Product
    Cucumber w/ Ranch Snack Cup 850065403144 Net Wt: 9.5oz (269g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0453-2025·2025-02-05

    Yummi Sushi Bao Buns and Gyoza Recalled for Possible Salmonella Contamination

    Yummi Sushi is recalling Karaage Chicken Bao Buns and Gyoza Combo products due to possible Salmonella contamination. The affected products were distributed in Texas with a best-by date of 11/30/2024.

    Product
    Karaage Chicken Bao Buns UPC: 85006499045 Net Wt: 8.8 oz (251g) 11/22 to 11/29/2024 Gyoza Combo UPC: 85001442018 Qty: 11 pcs, Net Wt: 13.3 OZ (377g) 11/22 to 11/29/2024
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0450-2025·2025-02-05

    Sushi Products Recalled for Possible Salmonella Contamination

    GBC Food Services dba Yummi Sushi is recalling multiple prepared sushi products distributed in Texas due to possible Salmonella contamination. Products with code dates 11/22–11/29/2024 should not be consumed.

    Product
    Spicy Tuna with Spicy Mayo Roll UPC: 85375900839 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024 Spicy Tuna with Spicy Mayo Roll UPC: 85006061926 Qty: 1 Tray, Net Wt: 7.8oz (223g) 11/22 to 11/29/2024. Tuna Tataki Poke Bowl UPC: 85004566863 Net Wt: 14.5oz (412g) 11/22 to 11/
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0439-2025·2025-02-05

    Salad Recall: Southwest Salad from Yummi Sushi Due to Salmonella Risk

    GBC Food Services is recalling Southwest Salad products (6,088 units) distributed in Colorado due to potential Salmonella contamination. Products purchased between November 22-29, 2024 may be affected.

    Product
    Southwest Salad 850065403069 Net Wt: 4oz (113g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0446-2025·2025-02-05

    Vegetable Bowls Recalled Due to Potential Salmonella Contamination

    GBC Food Services is recalling 6,088 vegetable bowls due to potential Salmonella contamination. The affected products were purchased between November 22-29, 2024, and distributed in Colorado.

    Product
    Vegetable Bowl 860010507131 26 oz (738g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0991-2025·2025-02-05

    Medline Arterial Line Insertion Kits Recalled for Catheter Hub Defect

    Medline Industries is recalling 942 arterial line insertion kits due to excess material on the catheter hub of the catheter subassembly. The manufacturing defect prompted a FDA Class I recall of products distributed nationwide.

    Product
    Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE BUNDLE, Item Number ART355; 5) ARTERIAL LINE BUNDLE, Item Number ART355 ; 6)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0447-2025·2025-02-05

    Vegetable bowl recalled due to potential Salmonella contamination

    GBC Food Services' Vegetable Bowl is being recalled due to potential Salmonella contamination. Products purchased in Colorado between November 22–29, 2024 may be affected.

    Product
    Vegetable Bowl 850065403380 13 oz (368g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0444-2025·2025-02-05

    Family Cobb Salad Recalled for Potential Salmonella Contamination

    GBC Food Services, LLC (dba Yummi Sushi) is recalling Family Cobb Salad due to potential Salmonella contamination. The affected product was distributed in Colorado.

    Product
    Family Cobb Salad 850054894625 22 oz (623g)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0427-2025·2025-02-05

    Simple Truth Organic Broccoli Florets Recalled for Potential Listeria Contamination

    Simple Truth Organic Broccoli Florets have been recalled due to potential contamination with Listeria monocytogenes. The affected product is a 12oz steam-in-bag broccoli from Mexico with a best-if-used-by date of November 8, 2024.

    Product
    Simple Truth Organic, BROCCOLI FLORETS, STEAM IN BAG, 12oz, BEST IF USED BY NOV 08 2024, PRODUCT OF MEXICO
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0431-2025·2025-02-05

    Frozen peach mango sorbet recalled for undeclared egg allergen

    The Mochi Ice Cream Company is recalling My Mochi Sorbet Peach Mango Sorbet nationwide due to undeclared egg allergen. Consumers with egg allergies should not consume this product.

    Product
    My Mochi Sorbet Peach Mango Sorbet; Keep Frozen; 6 pieces per container; 6-1.25 OZ (35g) PIECES NET WT 7.5 OZ (210g)*** Nutritional Panel: 6 servings per container; JOYFULLY CHILL!; Made in a nut-free facility; Made by My/Mochi, 5563 Alcoa Ave., Los Angeles, CA 90058; www.mymochi
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0448-2025·2025-02-05

    Multiple Sushi Products Recalled for Possible Salmonella Contamination

    GBC Food Services is recalling multiple Yummi Sushi varieties due to possible Salmonella contamination. The affected products were distributed in Texas and have best-by dates of 11/30/2024.

    Product
    Multiple varieties of sushi: Cheetos¿ Flamin' Hot¿ California Roll UPC: 85005520995 Net Wt: 10.1 oz (286g) 11/22 to 11/29/2024 Spicy Crunchy Yummi Roll UPC: 85375900882 Qty: 1 Tray, Net Wt: 11oz (312g) 11/22 to 11/29/2024 Tornado Roll UPC: 85375900885 Qty: 1 Tray, Net Wt: 11oz (
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0452-2025·2025-02-05

    Yummi Sushi salmon products recalled for possible Salmonella contamination

    GBC Food Services is recalling Yummi Sushi salmon products distributed in Texas due to possible Salmonella contamination. The recall affects products produced November 22-29, 2024.

    Product
    Spicy Salmon Roll UPC: 85375900865 Qty: 1 Tray, Net Wt: 8.1oz (230g) 11/22 to 11/29/2024 Fusion Spring Roll (Salmon) UPC: 85375900891 Qty: 1 Tray, Net Wt: 7.2oz (204g) 11/22 to 11/29/2024 Grilled Salmon Roll UPC: 85694200877 Qty: 1 Tray, Net Wt: 10oz (284g) 11/22 to 11/29/2024 Se
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0451-2025·2025-02-05

    Multiple Sushi Rolls Recalled for Possible Salmonella Contamination

    Yummi Sushi has recalled multiple shrimp-based sushi roll products distributed in Texas due to possible Salmonella contamination. Consumers should not consume these products and should return them to the point of purchase.

    Product
    Tempura Shrimp Roll UPC: 85375900884 Qty: 1 Tray, Net Wt: 10oz (284g) 11/22 to 11/29/2024 Spicy Cajun Shrimp Roll UPC: 85006499076 Net Wt: 10.8 oz (305g) 11/22 to 11/29/2024 Shrimp Combo UPC: 85001442019 Qty: 7 pcs, Net Wt: 12.2 OZ (347g) 11/22 to 11/29/2024 Shrimp Avocado Roll
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0210-2025·2025-02-05

    FDA Class I Recall: Astagraf XL Immunosuppressant Capsules May Be Empty

    Astellas Pharma is recalling Astagraf XL (tacrolimus) due to manufacturing defects; bottles shipped nationwide may contain empty capsules instead of medication.

    Product
    ASTAGRAF XL — ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2025·2025-02-05

    Karl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath Detachment Recall (47 Units)

    Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0456-2025·2025-02-05

    BakeMark USA Recalls Bavarian Creme Filling Due to Thermal Processing Deviation

    BakeMark USA recalls WESTCO 3065 Golden Bavarian Creme Filling due to a thermal processing deviation that may result in inadequate heat treatment. The product was distributed to 22 states.

    Product
    WESTCO 3065 GOLDEN BAVARIAN CREME FILLING ARTIFICIALLY FLAVORED Ingredients: Water, Sugar, Modified Food Starch, Contains 2% or Less of: Artificial Flavor, Salt, Color (Titanium Dioxide, Yellow 5, Yellow 6), Preservatives (Sodium Benzoate, Sorbic Acid, Potassium Sorbate, Phosphor
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-0440-2025·2025-02-05

    Cobb Salad Recalled Due to Potential Salmonella Contamination

    GBC Food Services is recalling Individual Cobb Salad products due to potential Salmonella contamination. The affected products were distributed in Colorado with purchase dates between November 22–29, 2024.

    Product
    Individual Cobb Salad 850054894632 11 oz (311g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1049-2025·2025-02-05

    Medline arterial line catheter packs recalled for missing heparin coating

    Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.

    Product
    MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1050-2025·2025-02-05

    BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets

    The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.

    Product
    BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Food)·F-0433-2025·2025-02-05

    LuLu Chinese Express frozen shrimp meal lacks soy allergen labeling

    LuLu Chinese Express Sweet and Sour Shrimp with Fried Rice is being recalled because soy allergen information is missing from the label. Consumers with soy allergies face a serious health risk.

    Product
    LuLu Chinese Express, Sweet and Sour Shrimp w/ Fried Rice, Net Wt. 16 oz (1 lb), UPC 2393329006, packaged in plastic container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1020-2025·2025-02-05

    HemosIL Heparin Calibrators Recalled Over Quality Control Test Failures

    Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.

    Product
    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2025·2025-02-05

    Medical stent delivery system outer sheath component detachment prevents proper expansion

    The HOT AXIOS Stent delivery system's outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange. Boston Scientific is recalling 1,102 units distributed nationwide.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2025·2025-02-05

    Knee Implant Component Recalled for Incorrect Metal Post Assembly

    Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.

    Product
    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2025·2025-02-05

    Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2025·2025-02-05

    Medline procedure kits recalled for surgical masks failing sterilization tests

    Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.

    Product
    Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2025·2025-02-05

    X-Ray System Recalled for Potential Excessive Radiation Dose in First Image

    Siemens ARTIS One X-ray systems may deliver higher radiation doses during first imaging after patient registration due to copper prefiltration malfunction occurring in very rare situations.

    Product
    ARTIS One Angiographic X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1037-2025·2025-02-05

    HOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk

    Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0457-2025·2025-02-05

    Mustard Products Recalled Due to Salmonella in Seeds

    Keith Valley and Red Boy brand mustards distributed in the South and Southwest are being recalled because mustard seeds tested positive for Salmonella. Consumers should not consume affected products.

    Product
    Keith Valley mustard, net 1 gal, Distributed by: Ben E Keith Food Ft Worth, TX, UPC 046045062467; Red Boy brand mustard, Net 1 GAL., Distributed by Clements Food Company Oklahoma City, OK 73116, UPC 071735128154
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1055-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1067-2025·2025-02-05

    Implantable VNS Therapy Generators May Stop Delivering Treatment

    LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.

    Product
    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2025·2025-02-05

    Medtronic Percutaneous Reference Pins May Not Fit Properly

    Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.

    Product
    Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove a pin percutaneously into bony patient anatomy for rigid attachment of a pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2025·2025-02-05

    Bedside cardiac monitor system recalled for display distortion

    The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2025·2025-02-05

    Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2025·2025-02-05

    Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure

    Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.

    Product
    Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2025·2025-02-05

    Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling a uretero-renoscope surgical device (REF 27003L) because the reprocessing instructions in the product documentation have not been reviewed or approved by the FDA.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0436-2025·2025-02-05

    FDA Recalls Cucumber Bowl with Ranch Dip Due to Salmonella Risk

    GBC Food Services is recalling Cucumber Bowls with Ranch dip purchased between November 22-29, 2024, due to potential Salmonella contamination. The recall affects 6,088 units distributed in Colorado.

    Product
    Cucumber Bowl with Ranch dip 850054894519 15oz (425g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1021-2025·2025-02-05

    Design Options Combined Spinal/Epidural Tray Recalled for Connector Defect

    B. Braun Medical is recalling 1,090 units of the Design Options Combined Spinal/Epidural Tray due to an incorrect catheter connector that cannot securely connect to the epidural catheter, preventing medication administration.

    Product
    Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2025·2025-02-05

    HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion

    Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2025·2025-02-05

    AXIOS Stent Delivery System recalled due to distal sheath detachment

    Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.

    Product
    AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2025·2025-02-05

    Alphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse

    Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.

    Product
    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0432-2025·2025-02-05

    Diced Bartlett Pears recalled for potential foreign object contamination

    Pacific Coast Producers is recalling diced Bartlett pears in syrup due to potential contamination with foreign objects. The affected product was distributed in Kentucky, Michigan, Ohio, and Pennsylvania.

    Product
    Diced Bartlett Pears In Extra Light Syrup, 105 OZ (6 LB 9 OZ), packed in a metal can, hermetically sealed
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1064-2025·2025-02-05

    Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2025·2025-02-05

    AXIOS Stent Distal Tip Detachment Prevents Proper Expansion

    Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0455-2025·2025-02-05

    Alpha Test supplement capsules recalled for unapproved cathine ingredient

    Iovate Health Sciences is recalling Alpha Test 120-count capsules containing cathine, an unapproved ingredient not permitted in dietary supplements. Affected products were distributed across the United States and internationally.

    Product
    Alpha Test 120 count Black labeled plastic bottle, 12 bottles per case of 120 count capsules each per bottle, Store in a cool, dry place (60 F to 80 F), UPC 6-31656-60676-8, SKU0001191, SKU0002075
    Category
    Drug
    Distribution
    30 states
  • HighNHTSA·25V056000·2025-02-05

    2025 Honda Pilot third-row seat belt may not restrain occupant

    Honda is recalling certain 2025 Pilot vehicles because the third-row passenger seat belt may not function due to incorrect routing. A non-functioning seat belt cannot properly restrain occupants, increasing injury risk during a crash.

    Product
    HONDA — HONDA PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2025·2025-02-05

    Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy

    LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.

    Product
    Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2025·2025-02-05

    CyberKnife Treatment System: Internal Snap Ring Detachment Risk

    Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.

    Product
    CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2025·2025-02-05

    Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled

    Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2025·2025-02-05

    Knee implant articular surface recalled for incorrect metal post assembly

    Zimmer, Inc. is recalling NexGen LCCK knee implant articular surface components due to incorrect assembly of the metal support post. The defect was identified internally in a small number of units.

    Product
    NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2025·2025-02-05

    Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2025·2025-02-05

    Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment

    Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2025·2025-02-05

    Infinity Central Station speakers may fail to produce critical patient alarms

    Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.

    Product
    Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of dat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2025·2025-02-05

    Infusion catheters recalled for missing antimicrobial heparin coating

    Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.

    Product
    CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1053-2025·2025-02-05

    Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2025·2025-02-05

    AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion

    Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2025·2025-02-05

    Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2025·2025-02-05

    Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions

    Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2025·2025-02-05

    Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity

    Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2025·2025-02-05

    AXIOS Stent and Delivery System Recalled for Improper Expansion Risk

    The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.

    Product
    AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2025·2025-02-05

    AXIOS stent delivery system outer sheath detachment prevents proper expansion

    Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2025·2025-02-05

    Karl Storz Pediatric Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2025·2025-02-05

    Stent system outer sheath may detach, preventing proper expansion

    Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2025·2025-02-05

    Outer Sheath Detachment in HOT AXIOS Stent Delivery System

    Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath May Detach During Use

    The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2025·2025-02-05

    Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide

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