The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

226–250 of 6113

  • SevereFDA (Devices)·Z-1879-2026·2026-04-29

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1931-2026·2026-04-29

    LSL Healthcare Infant Central Line Dressing Change Kit Recalled

    LSL Healthcare is recalling its Infant Central Line Dressing Change Kit (Model 2925H) distributed nationwide because it contains Webcol Large Alcohol Prep Pads that were recalled for non-sterility.

    Product
    LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1869-2026·2026-04-29

    Soft-Vu Angiographic Catheter Recalled Due to Manufacturing Defect

    Angiodynamics, Inc. is recalling Soft-Vu Angiographic Catheter (Straight Art, Non-Braided) units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.

    Product
    Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1837-2026·2026-04-29

    Medline PICC Tray Model DYNJ41648A regulatory clearance rescinded

    Medline Industries has recalled its PICC Tray (Model DYNJ41648A) because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded by FDA.

    Product
    Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1844-2026·2026-04-29

    Medline medical device kits recalled for regulatory compliance rescission

    Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.

    Product
    Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1892-2026·2026-04-29

    Medline Convenience Kits with Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling Convenience Kits containing 10mL polycarbonate colored syringes because the products were modified in ways not approved by the FDA. The kits were distributed nationwide and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1890-2026·2026-04-29

    Medline Convenience Kits with 10mL Polycarbonate Colored Syringes Recalled

    Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOVASCULAR PACK-LF DYNJ0429339L, DYNJ0429339M ANGIO ARTERIOGRAM PACK-LF DYNJ0774026K ANGIO KIT PACK DYNJ83746B ANGIO TRAY NO LIDO DYNJ85557A ANGIOGRAPHY PACK II DYNJ1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0496-2026·2026-04-29

    Dextrose Injection USP recalled due to sterility assurance concerns

    B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2026·2026-04-29

    Medline angiography and catheter kits subject to rescinded regulatory clearances

    Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.

    Product
    Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Nu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1878-2026·2026-04-29

    Medline Convenience Kits with Colored Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling multiple Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects products distributed worldwide including the US, Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2026·2026-04-29

    IV Start Kit with Non-Sterile Alcohol Prep Pads Recalled

    LSL Healthcare is recalling IV Start Kits containing Webcol Large Alcohol Prep Pads due to non-sterility concerns. The affected kits were distributed nationwide in Maryland, Illinois, and Minnesota.

    Product
    LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1845-2026·2026-04-29

    Medline Labor Pack medical device kits regulatory clearance rescinded

    Medline Industries is recalling certain Labor Pack kits (Model DYNJ44813D) nationwide because their 510(k) regulatory clearances for Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.

    Product
    Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0489-2026·2026-04-29

    Harrow Eye FRESHKOTE Lubricant Eyedrops Sterile 10mL Recall

    Harrow Eye LLC is recalling FRESHKOTE Lubricant Eyedrops because the manufacturer cannot guarantee the product remains sterile. Affected lots are 1X68 and 1X69, with an expiration date of 05/31/2027.

    Product
    FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0497-2026·2026-04-29

    Sodium Chloride for Irrigation Lacks Sterility Assurance

    B. Braun Medical Inc. is recalling sodium chloride for irrigation solution (3000 mL bags) due to lack of assurance of sterility and potential leakage from the diaphragm port. Affected lots distributed nationwide have expiration dates through May 31, 2028.

    Product
    SODIUM CHLORIDE FOR IRRIGATION — SODIUM CHLORIDE FOR IRRIGATION (SODIUM CHLORIDE FOR IRRIGATION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2026·2026-04-29

    Medline 10mL Polycarbonate Syringes in Convenience Kits recalled

    Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF DYNJ022088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1886-2026·2026-04-29

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0666-2026·2026-04-29

    Salute Seasonings Ground All Spice Recalled for Salmonella Contamination

    Unistel Industries is recalling SALUTE SEASONINGS Ground All Spice due to potential Salmonella contamination. Affected lot codes A6040, A6054, and A6068 were distributed in California, Hawaii, and Washington.

    Product
    SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·H-0682-2026·2026-04-29

    Kirkland Signature Madeleines recalled for undeclared hazelnut and soy

    Costco is recalling Kirkland Signature Traditional Madeleines because they contain undeclared hazelnut and soy lecithin, which are not listed on the label. Consumers with allergies to these ingredients should not consume the product.

    Product
    Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is packed with 9 pieces of Filled Heart Madeleines. Distributed by Costco Wholesale Corp. Seattle, WA. Label of recalled package is read in part: TRAD
    Category
    Food
    Distribution
    8 states
  • SevereCPSC·26435·2026-04-23

    32 Degrees Heated Socks Recalled Due to Burn Hazard

    32 Degrees Heated Socks sold at Costco from August 2025 to March 2026 are recalled due to burn hazard. When worn during high-intensity activities, the socks can cause first- or second-degree burns.

    Product
    32 Degrees Heated Socks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26432·2026-04-23

    Children's Tower Stools Recalled Due to Collapse and Entrapment Hazards

    TOETOL tower stools can collapse or tip over while in use. Children's torsos can fit through side openings, creating entrapment risks. The firm received 18 collapse reports with 11 injuries.

    Product
    TOETOL Tower Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26430·2026-04-23

    Wiifo Children's Tower Stools Recalled for Collapse, Tip-Over, and Entrapment Hazards

    Approximately 9,700 Wiifo Children's Tower Stools may collapse or tip over, with children's torsos able to fit through side openings, risking serious injury or death. The firm has reported 22 collapse incidents resulting in 6 injuries.

    Product
    Wiifo Children's Tower Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·26431·2026-04-23

    Adjustable dumbbells recalled for dislodging weight plates causing injuries

    About 50,000 FitRx SmartBell adjustable dumbbells are recalled because weight plates can dislodge during use. There have been at least 6 documented injuries including broken toes, bruises, contusions, and lacerations.

    Product
    FitRx SmartBell Quick-Select 5-52.5lbs Adjustable Dumbbells
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1801-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Accumulation

    B. Braun is recalling hemodialysis bloodlines (Model SL-2000M2095L) due to potential air bubble accumulation in the arterial line under negative pressure. Approximately 328,640 units distributed worldwide are affected.

    Product
    B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1802-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled Due to Air Bubble Accumulation Risk

    B. Braun has recalled hemodialysis bloodlines due to potential air bubble accumulation in the arterial line. The recall affects 4,848 units distributed nationwide and in Canada.

    Product
    B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2026·2026-04-22

    B. Braun Hemodialysis Bloodlines Recalled for Potential Air Bubble Accumulation

    B. Braun is recalling STREAMLINE BLOODLINE SET hemodialysis devices due to potential air bubble accumulation in the arterial line. The recall affects 3,158,104 units.

    Product
    B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
    Category
    Medical Device
    Distribution
    Distributed nationwide