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.

826–850 of 50462

  • HighFDA (Devices)·Z-2458-2026·2026-06-24

    Ritmed non-sterile neurological sponges may exceed endotoxin specification for cerebrospinal contact

    Ritmed non-sterile Neurological Sponges across seven sizes are being recalled because they may not consistently meet the endotoxin specification for devices contacting cerebrospinal fluid.

    Product
    Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2464-2026·2026-06-24

    ConMed AirSeal 5mm smooth access ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Smooth Access Ports and Obturators with Blunt Tip are being recalled because of the potential for overpressure alerts. 497 packs, or 2,982 units, are affected.

    Product
    ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-1079-2026·2026-06-24

    Adndale magnesium glycinate gummies contain undeclared melatonin in three lots

    Adndale Magnesium Glycinate Gummies 400 mg are being recalled because of undeclared melatonin. The action covers 13,920 bottles.

    Product
    Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2486-2026·2026-06-24

    Medline cardiac surgery and ECMO packs contain substandard catheters

    Medline cardiac procedure kits including basic heart, cardiac surgery, carotid endarterectomy and ECMO packs are being recalled over catheter specification failures. 4,801 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2497-2026·2026-06-24

    Medline bioburden test and cystectomy kits contain substandard catheters

    Medline procedure kits including the Bioburden Test Kit and Kit Uro Robot Cystectomy are being recalled because sample catheters did not meet performance specifications. 123,030 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0594-2026·2026-06-24

    Aripiprazole 30mg bottle contained voriconazole 50mg tablets instead

    Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.

    Product
    ARIPIPRAZOLE — ARIPIPRAZOLE (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2475-2026·2026-06-24

    Giraffe OmniBed incubator canopy fasteners can fall into patient compartment

    Giraffe OmniBed incubator-warmers, all models, are being recalled because fasteners securing the canopy soffit can disengage and fall into the patient compartment. 19,587 units affected.

    Product
    Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2026·2026-06-24

    Medline gynaecology laparoscopy packs contain catheters failing performance specifications

    Medline gynaecology procedure kits including basic GYN, D&C hysteroscopy and GYN laparoscopy packs are being recalled over catheter specification failures. 44,656 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2495-2026·2026-06-24

    Medline urethroplasty kits contain catheters failing performance specifications

    Medline urology urethroplasty procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 91 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU DYKMBNDL117C; 2) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978; 3) URETHROPLASTY, Medline Kit Number/SKU DYNJ908978F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0949-2026·2026-06-24

    Great Value Hawaiian Rolls Recalled Due to Oily Packaging Substance

    United States Bakery is recalling Great Value Hawaiian Rolls due to an oily and sticky substance found on the packaging's food contact surface. The product was never sold to consumers and all affected product has been accounted for.

    Product
    Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase.…
    Category
    Food
    Distribution
    26 states
  • HighNHTSA·26V401000·2026-06-24

    Airstream Recalls 2025-2027 Vehicles Due to Rooftop Fan Fire Risk

    Airstream is recalling 2025-2027 Interstate and 2026 Classic recreational vehicles because a rooftop ventilation fan component may overheat and cause a fire.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE, CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2026·2026-06-24

    ConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts

    ConMed AirSeal 12 mm Access Ports and Obturators with Blunt Tip, 100 mm length, are being recalled because of the potential for overpressure alerts. 1,261 packs affected.

    Product
    ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2487-2026·2026-06-24

    Medline open heart and cardiac kits contain catheters failing specifications

    Medline open heart and cardiac procedure kits are being recalled because representative samples did not meet applicable catheter performance specifications. 168,968 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2026·2026-06-24

    ConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 8 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2026·2026-06-24

    Medline vasectomy reversal kits contain catheters failing performance specifications

    Medline Bilateral Micro Vasectomy Reversal kits are being recalled because representative samples did not meet applicable catheter performance specifications. 588 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2026·2026-06-24

    Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

    Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2026·2026-06-24

    ConMed AirSeal 5mm 120mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 120 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2026·2026-06-24

    ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 100 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2469-2026·2026-06-24

    ConMed AirSeal 5mm 75mm optical obturator ports may trigger overpressure alerts

    ConMed AirSeal 5 mm Access Ports with Low Profile Bladeless Optical Tip Obturators, 75 mm length, are being recalled because of the potential for overpressure alerts.

    Product
    ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0596-2026·2026-06-24

    Buprenorphine injection vials show crystallization identified as buprenorphine free base

    Buprenorphine HCl Injection, 0.3 mg/mL single dose vials, is being recalled because of crystallization identified as buprenorphine free base. 46,334 units are affected.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2026·2026-06-24

    Medline nursing kits contain catheters failing applicable performance specifications

    Medline Nursing Kits, SKU EDUC1044, are being recalled because representative samples did not meet applicable catheter performance specifications. 730 units are affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2491-2026·2026-06-24

    Medline tracheostomy and tonsil kits contain catheters failing specifications

    Medline procedure kits including adult tracheostomy tube insertion, T&A and ear packs are being recalled because sample catheters did not meet performance specifications. 217,390 units affected.

    Product
    MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SINUS, EAR PACK, etc. (see the recall documents for the full list of products)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E037000·2026-06-23

    Rockford Fosgate Amplifier Kits Recalled for Fire Risk

    Rockford Corporation is recalling specific amplifier kits because a fuse may fail to protect against short circuits, increasing the risk of a fire.

    Product
    ELECTRICAL SYSTEM:WIRING:FUSES AND CIRCUIT BREAKERS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide