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.

25001–25025 of 50443

  • HighFDA (Devices)·Z-2373-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recall Due to Tip Breakage

    Bard Peripheral Vascular Inc is recalling 161 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2413-2019·2019-09-04

    Stryker Endotrac ECTR Push Blade Recalled for Sterile Bag Seal Integrity

    Stryker GmbH is recalling 476 Endotrac ECTR Push Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2370-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Damage

    Bard Peripheral Vascular Inc is recalling 40 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2117-2019·2019-09-04

    Olive Bakery Peanut Butter Bread Recalled for Allergen Mislabeling

    Olive Bakery is recalling Peanut Butter Bread packages because the label fails to declare wheat and soy lecithin. The product was distributed in Oregon and Washington.

    Product
    Peanut Butter bread packages contain two bread pastries filled with peanut butter filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2364-2019·2019-09-04

    CooperSurgical Recalls TransWarmer Infant Mattresses Due to Burn Risk

    CooperSurgical is recalling TransWarmer Warming Infant Transport Mattresses because some units lack updated instructions prohibiting use with other heat devices, which could cause skin burns.

    Product
    TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 570 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2120-2019·2019-09-04

    Olive Bakery Recalls Red Bean and Walnut Bread for Allergen Mislabeling

    Olive Bakery is recalling three packages of red bean and walnut bread sold in Oregon and Washington due to undeclared wheat and walnut allergens.

    Product
    Red/ Walnut bread packages contain two bread pastries filled with red bean paste filling coated with egg on the outside and topped with walnuts. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2115-2019·2019-09-04

    Olive Bakery Recalls Bavarian Bread Packages for Allergen Mislabeling

    Olive Bakery is recalling three packages of Bavarian bread pastries because the label fails to declare wheat and soy lecithin.

    Product
    Bavarian bread packages contain two bread pastries filled with Bavarian cream filling. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label. The packaging contains white printing…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2402-2019·2019-09-04

    Siemens SOMATOM go.All CT Scanner Recall for Falling Injector Holder

    Siemens is recalling 10 SOMATOM go.All CT scanners because the injector holder could fall off. The units are distributed in 20 US states.

    Product
    SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19778·2019-09-04

    John Deere Recalls Frontier Grooming Mowers Due to Entanglement Hazard

    John Deere is recalling Frontier grooming mowers because incorrect driveline assembly can prevent the safety shield from spinning, posing an entanglement injury risk.

    Product
    Frontier FM3012, GM1060, GM1072, GM1084, GM1190, GM3060, and GM3072 grooming mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2393-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 91 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2384-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled for Molded Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2394-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 39 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2381-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling 2 units of Equistream XK hemodialysis catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2391-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2376-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2112-2019·2019-09-04

    Olive Bakery Peanut Crunch Bread Recalled for Wheat Labeling Error

    Olive Bakery is recalling five packages of Peanut Crunch bread because the label declares flour but fails to declare wheat, a major allergen.

    Product
    Peanut Crunch bread packages contain two bread pastries with no filling and topped with a peanut butter crunch on the outside. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or nutritional information is included on the label.…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2361-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled Due to Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2369-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 135 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2400-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling 18 SOMATOM go.Up CT systems because the injector holder could fall off, posing a risk of injury.

    Product
    SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-2118-2019·2019-09-04

    Olive Bakery Chestnut Bread Recalled for Undeclared Wheat Allergen

    Olive Bakery is recalling chestnut bread packages because the label declares flour but fails to declare wheat, a major food allergen.

    Product
    Chestnut bread packages contain two bread pastries filled with white bean paste filling and topped with sesame seeds on the outside. Product does NOT contain any chestnut. They are packaged together in a clear plastic bag with a fold down stick seal. No net weight or…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2387-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2392-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recall Due to Tip Damage

    Bard Peripheral Vascular Inc is recalling 887 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2385-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
    Category
    Medical Device
    Distribution
    53 states