The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

3201–3225 of 52938

  • HighCPSC·26037·2025-10-23

    Adult portable bed rails recalled over entrapment and asphyxiation risk

    LEACHOI Bed Rails are being recalled because users can become entrapped within the rail or between the rail and the mattress, and the rails lack required hazard warning labels.

    Product
    LEACHOI Bed Rail
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2026·2025-10-22

    Bipolar femoral heads recalled over packaging that may compromise sterility

    BioPro is recalling 147 bipolar heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

    Product
    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BI
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0194-2026·2025-10-22

    Three valve retractable collar sets recalled across many lots for leak potential

    Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0044-2026·2025-10-22

    Strawberry milk pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 30 units of Wawa Strawberry Lowfat Milk in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa Strawberry Milk, Lowfat Milk, 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191015134
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0181-2026·2025-10-22

    Caesarean section packs recalled after being sterilized more than once

    American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0058-2026·2025-10-22

    Aluminium cookware sets recalled for containing elevated levels of lead

    Goyal Group is recalling 293 sets of Silver Horse aluminium milk pans and mathar kadai cookware because they contain elevated levels of lead.

    Product
    1. SILVER HORSE - PURE ALUMINIUM MADE IN INDIA - ALUMINIUM MILK PAN 4 inches 2. SILVER HORSE - ALUMINIUM MATHAR KADAI - 26 inches
    Category
    Consumer Product
    Distribution
    13 states
  • HighFDA (Devices)·Z-0170-2026·2025-10-22

    Basic biopsy trays recalled after entire lot was sterilized more than once

    American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Basic Biopsy Tray, Item Number NMBP44L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2026·2025-10-22

    Extension IV sets recalled from one lot because the sets may leak

    Baxter is recalling 16,416 CLEARLINK System straight-type extension sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0043-2026·2025-10-22

    Whole milk pints recalled over potential foreign object contamination

    Wawa Beverage Company is recalling 154 units of Wawa whole milk in 16 oz bottles for potential foreign object contamination.

    Product
    Wawa HVD (Whole) Milk , 16 oz (Pint), Plastic bottle, Stored refrigerated, UPC: 00726191014403
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0186-2026·2025-10-22

    PICC and gastrostomy tube packs recalled after being sterilized more than once

    American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2026·2025-10-22

    Non-vented IV solution sets recalled from one lot because sets may leak

    Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0202-2026·2025-10-22

    Three valve solution sets recalled from one lot because sets may leak

    Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2026·2025-10-22

    CX preconnect pumps without InhibiZone recalled over inflation deflation issues

    Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.

    Product
    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2026·2025-10-22

    Angiography procedure packs recalled after being sterilized more than once

    American Contract Systems is recalling angiography and coronary convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.

    Product
    Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2026·2025-10-22

    Three valve filtered solution sets recalled because IV sets may leak

    Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.

    Product
    CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

    MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.

    Product
    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2026·2025-10-22

    Six foot display cables recalled over inadequate shielding and interference

    Spacelabs Healthcare is recalling 8,179 six-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2026·2025-10-22

    LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values

    GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.

    Product
    LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2026·2025-10-22

    Monitor display cables recalled over inadequate shielding and electromagnetic interference

    Spacelabs Healthcare is recalling 16,898 DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.

    Product
    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2026·2025-10-22

    Stopcock extension solution sets recalled from two lots because sets may leak

    Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.

    Product
    CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2026·2025-10-22

    Cardiac Workstation 7000 recalled after pinched power module wire caused short

    Philips is recalling 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.

    Product
    Cardiac Workstation 7000; Model Number: 860441;
    Category
    Medical Device
    Distribution
    Distributed nationwide