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.

25676–25700 of 50447

  • HighFDA (Devices)·Z-1674-2019·2019-06-05

    Maquet Getinge Custom Neonatal ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal extracorporeal circulation tubing sets because a design feature may prevent proper sterilization gas flow, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2019·2019-06-05

    Maquet Getinge-T 8030 High Flow Pigtail Tubing Recalled for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2019·2019-06-05

    Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling Custom Tubing Sets for Extracorporeal Circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1661-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Recall for Sterility Assurance

    Maquet Cardiovascular is recalling specific ECC pump packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V417000·2019-06-05

    Thor Motor Coach Recalls 2019-2020 Magnitude and Omni Motorhomes for Fire Risk

    Thor Motor Coach is recalling 2019-2020 Magnitude and Omni motorhomes because wires in the electrical junction box may contact an extra screw, increasing the risk of an electrical short circuit and fire.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH MAGNITUDE, OMNI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2019·2019-06-05

    Maquet Getinge Neonate Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonate tubing sets because a design feature may prevent sterilization gas from reaching all parts of the device.

    Product
    Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2019·2019-06-05

    Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2019·2019-06-05

    Teleflex Medical Recalls RUSCH LASERTUBE Due to Laser Guard Foil Separation

    Teleflex Medical is recalling 1,787 units of RUSCH LASERTUBE (Rubber) because the laser guard foil partially separated or detached at the edges.

    Product
    RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.

    Product
    Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1663-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2019·2019-06-05

    Maquet Getinge ECC Pump Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1518-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2019·2019-06-05

    Maquet Getinge Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2019·2019-06-05

    Maquet Getinge-BEQ-T 53400 Adaption Pack Recall for Sterility Assurance Issues

    Maquet Cardiovascular is recalling specific batches of Custom Tubing Sets for Extracorporeal Circulation because the stopcock design may prevent proper sterilization.

    Product
    Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2019·2019-06-05

    Maquet Pediatric Extracorporeal Circulation Tubing Sets Recalled for Sterility Concerns

    Maquet Cardiovascular is recalling specific pediatric tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2019·2019-06-05

    Maquet Getinge-BEQ-TOP 35503 SGD Pack Recall Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2019·2019-06-05

    Maquet Getinge Adult ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Adult ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2019·2019-06-05

    ThermaCare HeatWraps Recalled for Potential Skin Burn Risk

    PF Consumer Healthcare is recalling ThermaCare HeatWraps because some units may produce higher-than-specified temperatures, posing a risk of skin burns or blisters.

    Product
    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1423-2019·2019-06-05

    Paximadi Plain Biscotti Recalled for Undeclared Milk Allergen

    Paximadi Co. LLC is recalling Plain Biscotti because the label declares butter but fails to declare milk, a common allergen.

    Product
    Biscotti-Plain. Product is bulk packed in a master cardboard case and each master case contains either 48 or 36 individual biscotti. There are 12 Biscotti per layer and separated between layers with wax paper. Label applied to the exterior of master case only. The master…
    Category
    Food
    Distribution
    1 state