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.

40601–40625 of 50511

  • HighFDA (Devices)·Z-2288-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2240-2014·2014-08-27

    TomoTherapy H Series Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2014·2014-08-27

    TomoTherapy Hi-Art Software Recall for Potential Safety Anomalies

    Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1, and 1.2.2 due to identified potential safety issues.

    Product
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2342-2014·2014-08-27

    Renfro Foods Recalls Chile Con Queso for Undeclared Wheat

    Renfro Foods is recalling 16 oz. jars of Chile Con Queso because a supplier accidentally used wheat instead of whey in the cheese pre-mix.

    Product
    Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY STONEWALL KITCHEN; STONEWALL LANE, YORK MAINE 03909 USA 800-207-JAMS; STONEWALLKITCHEN.COM
    Category
    Food
    Distribution
    2 states
  • HighCPSC·14748·2014-08-27

    Sunjoy Multi-Purpose Outdoor Shelters Recalled for Fire Hazard

    Sunjoy is recalling about 2,000 multi-purpose outdoor shelters sold at BJ's Wholesale Club because the fabric canopy fails to comply with a voluntary flammability standard, posing a fire hazard.

    Product
    Multi-Purpose Outdoor Shelter
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2014·2014-08-27

    ICU Medical Recalls Port Access Kits with Potential Sterility Issues

    ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

    Product
    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2014·2014-08-27

    Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers

    Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.

    Product
    Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2296-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints about breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2258-2014·2014-08-27

    Smith & Nephew Recalls Trigen Intertan Nails Due to Manufacturing Error

    Smith & Nephew is recalling 601 units of Trigen Intertan nails because a manufacturing error caused the proximal lag screw hole to be positioned incorrectly.

    Product
    TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 11.5MM X 18 CM NAIL, 125o, REF 71675202, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2346-2014·2014-08-27

    Fish Family Farm Milk Recalled for Potential Peanut and Pistachio Contamination

    Fish Family Farm is recalling Grade A 2% Reduced Fat Milk due to potential contamination with peanuts and pistachios. The products were distributed in Connecticut and Massachusetts.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2294-2014·2014-08-27

    ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals

    ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2014·2014-08-27

    Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects

    Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.

    Product
    Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2014·2014-08-27

    Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

    Zimmer, Inc. is recalling 190 units of Persona Tibial General Instrument Trays because incorrect bracket geometry may prevent proper sterilization of surgical instruments.

    Product
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central…
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2238-2014·2014-08-27

    Siemens Dimension Chemistry Wash Recalled for Inaccurate Test Results

    Siemens Healthcare Diagnostics is recalling Dimension Chemistry Wash lot RD41041 because it caused accuracy shifts in specific patient and QC test results.

    Product
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals (TASPs) after receiving complaints of breakage. This is a retrospective recall covering corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2344-2014·2014-08-27

    Brett Anthony Foods Recalls Sesame Ginger Dressing for Unlabeled Almond Allergen

    Brett Anthony Foods is recalling Sesame Ginger Dressing because almonds are not listed in the allergen warning statement despite being an ingredient.

    Product
    Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1542-2014·2014-08-27

    Baxter Recalls ProSol Amino Acid Injection Due to Particulate Matter

    Baxter Healthcare is recalling 6,204 bags of ProSol Amino Acid Injection because a retention sample contained particulate matter. The product was distributed nationwide.

    Product
    PROSOL — PROSOL (VALINE, LYSINE, HISTIDINE, ISOLEUCINE, LEUCINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Components Due to Breakage Complaints

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2341-2014·2014-08-27

    Renfro Foods Recalls XOCHITL Chipotle Queso Dip for Undeclared Wheat

    Renfro Foods is recalling XOCHITL Chipotle Queso Dip because a supplier accidentally used wheat instead of whey in the cheese pre-mix, creating an undeclared allergen.

    Product
    XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2262-2014·2014-08-27

    AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error

    AngioDynamics is recalling specific Uni*Fuse Infusion Systems because they may contain a guidewire that is too long. The recall covers 36 units distributed in the US and internationally.

    Product
    Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2014·2014-08-27

    FDA Recalls Apex Arc Hip Stem Devices Due to Surface Staining

    Omnilife Science Inc. is recalling 13 Apex Arc Hip Stem devices due to staining on the implant surface.

    Product
    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2245-2014·2014-08-27

    Zimmer Recalls Magna-Fx Cannulated Bone Screws Due to Leak Test Failure

    Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.

    Product
    Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2259-2014·2014-08-27

    Medtronic Recalls Six Activa PC Implantable Neurostimulators

    Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

    Product
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic…
    Category
    Medical Device
    Distribution
    4 states