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.

41226–41250 of 50511

  • HighFDA (Drugs)·D-1306-2014·2014-05-14

    Mangiacotti Clementine Hand Sanitizer Spray Recalled for Bacterial Contamination

    Mangiacotti is recalling Clementine Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.

    Product
    Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2014·2014-05-14

    Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results

    Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.

    Product
    Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2014·2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.

    Product
    Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1562-2014·2014-05-14

    AlloSource Recalls AlloFuse DBM Putty Due to Donor Hemodilution

    AlloSource, Inc. is recalling 29 units of AlloFuse DBM Putty 5cc because the donor was hemodiluted. The product is used as a bone graft extender in orthopedic applications.

    Product
    AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1917-2014·2014-05-14

    Bread Stop Bakery Recalls Amaranth Bread Due to Undeclared Soy

    Bread Stop Bakery is recalling 100 loaves of Amaranth bread because soy lecithin was used in manufacturing but not declared on the label.

    Product
    the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-1305-2014·2014-05-14

    Mangiacotti Ocean Hand Sanitizer Spray Recalled for Bacterial Contamination

    Mangiacotti is recalling Ocean Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria. Consumers should stop using the product.

    Product
    Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2014·2014-05-14

    GE Healthcare Recalls Panda Wall-Mount Infant Warmers Due to Software Defect

    GE Healthcare is recalling 15 Panda Wall-Mount Infant Warmers because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1558-2014·2014-05-14

    Teleflex Medical Recalls Fixt Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Sutures because the needles may detach during use.

    Product
    Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1555-2014·2014-05-14

    Teleflex Recalls Deknatel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel nonabsorbable sutures because the needle may detach from the suture during use.

    Product
    Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1920-2014·2014-05-14

    Bread Stop Sourdough Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling 200 loaves of Sourdough Bread because soy lecithin was used in manufacturing but not declared on the label.

    Product
    the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1549-2014·2014-05-14

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Software Defect

    GE Healthcare is recalling 21 Panda Freestanding Infant Warmers worldwide because a software defect may cause false alarm notifications for oxygen saturation and pulse rate.

    Product
    Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1548-2014·2014-05-14

    GE Healthcare Recalls Panda iRes Infant Warmers Due to Alarm Defect

    GE Healthcare is recalling 723 Panda iRes Infant Warmers because defective software may cause false oxygen saturation and pulse rate alarms.

    Product
    Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1556-2014·2014-05-14

    Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.

    Product
    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1538-2014·2014-05-14

    Biorep Atrial Lift System Recalled for Support Arm Detachment

    Biorep Technologies is recalling the Joseph Lamelas Atrial Lift System because the support arm may detach from the blade body during use.

    Product
    Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1916-2014·2014-05-14

    Bread Stop Bakery Recalls Country White Bread for Undeclared Soy

    Bread Stop Bakery is recalling 150 loaves of Country White Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1551-2014·2014-05-14

    GE Healthcare Recalls Nellcor SpO2 Upgrade Kits Due to Software Defect

    GE Healthcare is recalling 301 Nellcor SpO2 Upgrade kits because a software defect may cause false positive or false negative oxygen saturation and pulse rate alarms.

    Product
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1919-2014·2014-05-14

    Bread Stop Honey Wheat Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling Honey Wheat Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1923-2014·2014-05-14

    Bread Stop Bakery Recalls Spelt and Millet Bread for Undeclared Soy

    Bread Stop Bakery is recalling 50 loaves of Spelt and Millet Bread because an anti-stick spray containing soy lecithin was used during manufacture, but soy was not declared on the label.

    Product
    the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2014·2014-05-14

    Teleflex Medical Recalls Stainless Steel Sutures Due to Needle Detachment Risk

    Teleflex Medical is recalling specific lots of Deknatel stainless steel sutures because the needle may detach from the suture during use.

    Product
    Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1915-2014·2014-05-14

    Wegmans Recalls Easter Bread for Undeclared Egg Allergen

    Wegmans is recalling 17-ounce Easter Bread loaves because they contain egg, which is not listed on the label.

    Product
    Scale label printed with "EASTER BREAD NET WT 17oz (1.06lb)" UPC 0 77890 32431 8, packaged in clear plastic bag
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1528-2014·2014-05-14

    INOmax DSIR Nitric Oxide Delivery System Recalled for Monitoring Anomaly

    INO Therapeutics is recalling 22 INOmax DSIR Nitric Oxide Delivery Systems due to a software anomaly that may trigger unintended alarms.

    Product
    INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1918-2014·2014-05-14

    Bread Stop Oatmeal Bread Recalled for Undeclared Soy Allergen

    Bread Stop Bakery is recalling 150 loaves of Oatmeal Bread because an anti-stick spray containing soy lecithin was used during manufacture, and soy was not declared on the label.

    Product
    the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1568-2014·2014-05-14

    Medtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets

    Medtronic is recalling specific Refill Kits for implantable infusion pumps because some contain occluded extension tubing that prevents filling. No patient injuries beyond additional needle sticks have been reported.

    Product
    Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14176·2014-05-14

    Cabela's Recalls Electronic Jerky Blaster Due to Fire Hazard

    Cabela's is recalling Electronic Jerky Blasters because the battery charger adapter can overcharge, causing the battery and adapter to overheat.

    Product
    Electronic Jerky Blaster
    Category
    Consumer Product
    Distribution
    Distributed nationwide