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.

13401–13425 of 22165

  • HighFDA (Devices)·Z-0333-2024·2023-11-29

    Gastroscope Devices Recalled for Inadequate Channel Drying Process

    Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.

    Product
    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2024·2023-11-29

    Hysteroscope Model HYF-1T recalled due to moisture in device channels

    Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.

    Product
    Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2024·2023-11-29

    Medical Device Cartridges Recalled for Blood Oxygen Reading Errors

    Instrumentation Laboratory is recalling GEM Premier 3000 PAK cartridges due to a defect that can produce falsely high blood oxygen readings. The inaccuracy may prevent detection of dangerously low oxygen levels and delay necessary treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0367-2024·2023-11-29

    V-Care manual resuscitators recalled for CO2 rebreathing defect

    SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.

    Product
    Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2024·2023-11-29

    Biomet Compress Device Anchor Plug Recall - Metal Burrs May Extend Surgery

    Biomet is recalling Compress Device Short Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through, potentially extending operative time.

    Product
    Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2024·2023-11-29

    Small intestinal videoscope recalled due to inadequate channel drying process

    Aizu Olympus is recalling small intestinal videoscopes (Model SIF-Q180) because the channel air drying process was not properly validated. Water remaining in the channels could cause contamination and infection risk.

    Product
    Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2024·2023-11-29

    Compress Device Anchor Plugs Recalled for Metal Burrs in Surgical Holes

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through properly. The defect may result in extended surgery time.

    Product
    Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2024·2023-11-29

    Boston Scientific EXALT Model D Duodenoscope Recall: Fluid Ingress in Lens

    Boston Scientific is recalling certain EXALT Model D Single-Use Duodenoscopes worldwide due to fluid ingress in the lens, which causes poor image quality. Affected devices should not be used; contact the manufacturer.

    Product
    EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2024·2023-11-29

    Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive

    Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.

    Product
    stryker Sage PrimaFit External Urine Management System for the Female Anatomy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0388-2024·2023-11-29

    Biomet Compress Device Short Anchor Plug recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (28 MM, Item 178570) due to potential metal burrs in transverse holes that may prevent surgical instruments from passing through, extending surgery duration.

    Product
    Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0383-2024·2023-11-29

    Biomet Compress Device Anchor Plug Recalled for Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (20 MM) because metal burrs in transverse holes prevent surgical instruments from passing through, potentially extending surgery time.

    Product
    Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2024·2023-11-29

    Avanos BALLARD Closed Suction System mislabeled for DEHP content

    Certain lots of AVANOS BALLARD Closed Suction System for Adults were labeled as DEHP-free but contain DEHP in tubing components. These units are used for mechanical ventilation and distributed in the US and South Africa.

    Product
    AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0378-2024·2023-11-29

    Biomet Compress Device Anchor Plugs recalled for metal burrs in transverse holes

    Biomet is recalling Compress Device Short Anchor Plugs due to potential metal burrs in the transverse holes that may prevent proper placement of drill pins during surgery, potentially extending surgical time.

    Product
    Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2024·2023-11-29

    Hand Sanitizer Recalled for Acetal and Acetaldehyde Contamination

    Integrity Biochem HSC 70-LM hand sanitizer in 55-gallon drums (Lot #2133607, manufactured 11/23/2021) is being recalled due to acetal and acetaldehyde contamination above FDA standards. Product was distributed to an Oklahoma distributor.

    Product
    Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0385-2024·2023-11-29

    Biomet Compress Device Short Anchor Plug Recalled Due to Metal Burrs

    Biomet is recalling Compress Device Short Anchor Plugs (23 MM) due to potential metal burrs in transverse holes that may prevent proper insertion of surgical instruments, potentially extending surgery time. Distribution includes US and multiple international countries.

    Product
    Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2024·2023-11-29

    Horizon manual resuscitators recalled for CO2 rebreathing hazard

    SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.

    Product
    Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Falsely Elevated Oxygen Readings

    Instrumentation Laboratory recalls GEM Premier 3000 PAK blood gas analyzer cartridges due to measurement errors in low oxygen detection. The devices may falsely indicate normal oxygen levels when levels are dangerously low, potentially delaying treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0358-2024·2023-11-29

    Blood Gas Analyzer Cartridges Recalled for Potential Oxygen Measurement Errors

    The FDA is recalling GEM Premier 3000 PAK cartridges manufactured by Instrumentation Laboratory because they may incorrectly report high oxygen levels in patients with low blood oxygen, potentially delaying critical treatment.

    Product
    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2024·2023-11-29

    Mobile Airway Scope Recalled Due to Unvalidated Drying Process

    Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.

    Product
    Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2024·2023-11-29

    Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled

    Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2024·2023-11-29

    Gastrointestinal videoscopes recalled due to unvalidated channel drying process

    Aizu Olympus is recalling 3,627 gastrointestinal videoscopes because the channel air drying process was not validated. A small percentage of devices returned after repair had wet channels, creating potential for contamination and risk of infection.

    Product
    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2024·2023-11-29

    Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.

    Product
    Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2024·2023-11-29

    Endoscopic surgical instruments recalled for unvalidated drying process

    Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.

    Product
    Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
    Category
    Medical Device
    Distribution
    Distributed nationwide