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.

36501–36525 of 50504

  • HighFDA (Devices)·Z-0957-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 76 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0991-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices Inc is recalling 40 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak out.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 38 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2016·2016-03-02

    Philips IntelliVue Module Measurement X2 Recall for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.

    Product
    Philips IntelliVue Module Measurement X2 Model: M3002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 162 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 235 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 243 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1005-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1003-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2016·2016-03-02

    Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation

    Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.

    Product
    Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 331 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 37 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage of feeding solution or gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1008-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 39 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2016·2016-03-02

    Olympus CF-H180AL Video Colonoscope Recalled for Detached Coil Pipe Assembly

    Integrated Medical Systems Inc. is recalling 232 Olympus CF-H180AL video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.

    Product
    Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2016·2016-03-02

    Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.

    Product
    Philips IntelliVue Measurement Module X1 Model: M3001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0950-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 77 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 91 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2016·2016-03-02

    Olympus Video Duodenoscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling 16 Olympus TJF-160F video duodenoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Detached Internal Coil Assembly

    Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD P/N 70-0050-B20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2016·2016-03-02

    Siemens Mammomat Inspiration Recall for Potential System Fatal Error

    Siemens is recalling 76 Mammomat Inspiration units because a system fatal error may occur during tomosynthesis reconstruction for large breasts, causing the process to abort.

    Product
    Mammomat Inspiration with Tomosynthesis functionality
    Category
    Medical Device
    Distribution
    Distributed nationwide