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.

38451–38475 of 50506

  • HighFDA (Devices)·Z-1721-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled Due to Breakage

    Vilex, Inc. is recalling 13 units of FUZE 10.0 mm x 150 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.

    Product
    Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1786-2015·2015-06-17

    Philips Recalls GEMINI TF PET/CT 16 Slice UPS Accessory Devices

    Philips is recalling 69 GEMINI TF PET/CT 16 Slice systems due to UPS accessory devices that may leak battery acid, overheat, or emit fumes.

    Product
    GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2015·2015-06-17

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry System software due to a defect that allows improper sample metering for urine assays requiring acidification.

    Product
    VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2397-2015·2015-06-17

    Reaction Nutrition Recalls L-Glutamine Powder for Potential Allergen Contamination

    Reaction Nutrition is recalling L-Glutamine Powder because it may contain undeclared whey protein and soy due to shared equipment use.

    Product
    RN BlueChip: Glutamine, L-Glutamine Powder, 400 grams, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2389-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor Carno Pump Plus Due to Allergen Cross-Contact

    Reaction Nutrition is recalling Bio Armor Carno Pump Plus Electrolytes because shared equipment may cause cross-contact with whey protein and soy.

    Product
    Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1791-2015·2015-06-17

    Philips Recalls BrightView SPECT UPS Accessory Devices for Safety Hazards

    Philips Medical Systems is recalling 277 BrightView SPECT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2015·2015-06-17

    Edwards Lifesciences Recalls ClearSight Heart Reference Sensor Due to Damage

    Edwards Lifesciences is recalling ClearSight Heart Reference Sensors because the finger component may be damaged. The recall affects 1,309 units distributed worldwide.

    Product
    ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1784-2015·2015-06-17

    Philips CardioMD III UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 81 CardioMD III UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1761-2015·2015-06-17

    Philips Recalls CT Scanner UPS Accessories Due to Battery Acid Leakage Risk

    Philips Medical Systems is recalling 788 Uninterruptible Power Supply (UPS) accessories for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2015·2015-06-17

    Philips Ingenuity TF UPS Accessory Devices Recalled for Battery Acid Leakage

    Philips Medical Systems is recalling 14 Ingenuity TF UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1753-2015·2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling 22,250 boxes of Diego Elite Tubesets due to a potential lack of sterility assurance. The devices are used for ENT and head and neck procedures.

    Product
    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2401-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplements Due to Undeclared Whey Protein

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein due to shared equipment use.

    Product
    REACTION RECOR: Amino Action- 500g (Island Breeze), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1759-2015·2015-06-17

    Philips Medical Systems Recalls MX 16 Slice UPS Accessory Devices

    Philips Medical Systems is recalling 125 MX 16 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1789-2015·2015-06-17

    Philips Recalls GEMINI TF Big Bore UPS Accessory Devices for Leakage Risk

    Philips Medical Systems is recalling 39 GEMINI TF Big Bore UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2015·2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling 32 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.

    Product
    R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2015·2015-06-17

    Ortho-Clinical VITROS 5600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to a software anomaly that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2015·2015-06-17

    Becton Dickinson Recalls BBL Port A Cul Tubes Due to Oxidation

    Becton Dickinson is recalling BBL Port A Cul tubes with Swabs Sterile Pack because excessive oxidation may affect the viability of anaerobic microorganisms.

    Product
    BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1769-2015·2015-06-17

    Philips iCT SP UPS Accessory Devices Recalled for Battery Acid Leakage Risk

    Philips Medical Systems is recalling 110 iCT SP UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2015·2015-06-17

    Vilex FUZE Ankle Arthrodesis Screws Recalled for Breakage

    Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm ankle arthrodesis screws due to a higher-than-expected incidence of breakage.

    Product
    Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-2391-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor CreaMatrix for Undeclared Allergens

    Reaction Nutrition is recalling Bio Armor CreaMatrix supplements because they may contain undeclared whey protein and soy.

    Product
    Bio Armor CreaMatrix 306g 60 servings Unflavored, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2015·2015-06-17

    Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect

    Smith & Nephew is recalling 17 units of the R3 Constrained Liner because the locking groove is oversized, potentially preventing the locking ring from engaging.

    Product
    R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2395-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplement Due to Undeclared Whey

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein, posing a risk to individuals with milk allergies.

    Product
    REACTION RECOR: Amino Action- 500g (Cherry Lime), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage

    Philips is recalling 25 Brilliance CT 6 Slice Air UPS accessories due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide