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.

36551–36575 of 50504

  • HighFDA (Devices)·Z-0904-2016·2016-03-02

    Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc. is recalling 54 Olympus GIF-Q160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1004-2016·2016-03-02

    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, allowing fluid to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) 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-0964-2016·2016-03-02

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

    Xeridiem Mediem Medical Devices Inc is recalling 126 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: M00548890 (XMD P/N 70-0050-820) 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-0995-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, causing leakage.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) 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-0969-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 38 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: M00548580 (XMD P/N 70-0050-916) 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-0929-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage

    Xeridiem Mediem Medical Devices is recalling 78 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: M00548680 (XMD P/N 70-0050-318) 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-0989-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for 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: M00548610 (XMD P/N 70-0050-C16) 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-0965-2016·2016-03-02

    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: M00549380 (XMD P/N 70-0050-822) 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-0971-2016·2016-03-02

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

    Xeridiem Mediem Medical Devices Inc is recalling 36 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: M00548900 (XMD P/N 70-0050-920) 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-0977-2016·2016-03-02

    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 solution or gastric contents to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2016·2016-03-02

    Olympus CF-Q140L Video Colonoscope Recalled for Internal Coil Detachment

    Integrated Medical Systems Inc is recalling two Olympus CF-Q140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach.

    Product
    Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0625-2016·2016-03-02

    Great Pacific Bagel & Cream Cheese Recalled for Undeclared Wheat

    Vern's & Son Food Service Distributing is recalling Great Pacific Bagel & Cream Cheese due to undeclared wheat. The product was distributed in Oregon and Washington.

    Product
    Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0961-2016·2016-03-02

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

    Xeridiem Mediem Medical Devices Inc. is recalling 36 EndoVive 3s Low Profile Balloon Kits due to a feeding valve leakage issue that may allow gastric contents to leak.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) 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-0908-2016·2016-03-02

    Olympus Pediatric Colonoscope Recalled for Potential Internal Coil Detachment

    Integrated Medical Systems Inc. is recalling one Olympus PCF-H190L video pediatric colonoscope because excessive pressure may cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2016·2016-03-02

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

    Xeridiem is recalling 260 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: M00548220 (XMD P/N 70-0050-112) 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-0886-2016·2016-03-02

    Teleflex Auto Endo5 Hem-o-lok Clip Applier Recall for Missing Boss

    Teleflex Medical is recalling Auto Endo5 Hem-o-lok clip appliers because the clip may be missing a boss, which is needed to hold the clip in the applier jaws.

    Product
    Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0997-2016·2016-03-02

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

    Xeridiem is recalling 40 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: M00549430 (XMD P/N 70-0050-D22) 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-0903-2016·2016-03-02

    Olympus CF-140L Video Colonoscope Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling nine Olympus CF-140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.

    Product
    Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for 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: M00549500 (XMD P/N 70-0050-624) 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-0896-2016·2016-03-02

    Olympus Video Colonoscopes Recalled Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc is recalling 82 Olympus CF-Q180AL video colonoscopes because excessive pressure may cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for 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: M00548300 (XMD P/N 70-0050-912) 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-0902-2016·2016-03-02

    Olympus Video Colonoscope Recall Due to Internal Coil Detachment Risk

    Integrated Medical Systems Inc. is recalling 43 Olympus CF-Q160AL video colonoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.

    Product
    Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2016·2016-03-02

    Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for 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: M00548470 (XMD P/N 70-0050-E14) 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-1009-2016·2016-03-02

    Xeridiem EndoVive 3s Balloon Kits Recalled for Valve Leakage

    Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may leak gastric contents or feeding solution when disconnected.

    Product
    EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) 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