There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
All Recalls
95,025 total recalls in our database
IceRod" He-Thaw Prostate Cryoablation Kit
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSeed" Prostate Cryoablation Kit
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
There is a potential that catheters may have incorrectly marked balloon and arterial lines. This could result in a procedure delay or injury to the patient.
IceRod" i-Thaw" Prostate Cryoablation Kit
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceRod" 1.5 MRI 90ΒΏ Cryoablation NeedleΒΏ
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IcePearl" 2.1 CX Prostate Cryoablation Kit
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSeed" 1.5ΒΏ MRI 90ΒΏ Cryoablation Needle ΒΏ
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
IceSphere" 1.5 90ΒΏ Cryoablation Needle
Boston Scientific
Complaint trend regarding needle shaft gas leaks.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
GA HEALTH COMPANY LIMITED
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Cloud Island infant rompers
Unknown Manufacturer
The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.
Cat & Jack Infant-Toddler One-Piece Rashguard Swimsuits
Unknown Manufacturer
The snaps can break or detach from the suits, posing choking and laceration hazards to children.
Chef Mitch Maier's Black Garlic Ketchup. Net Wt. 19 oz. (538g). UPC 8 60248-00254 5.
Out of the Kitchen
Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.
The firm was notified via a consumer complaint that the product contains the Lite Honey Mustard instead of the regular Honey Mustard. The Lite Honey Mustard contains milk which is not listed on the label.
Sour Cherry Baked Brie was recalled because the scale label, which was printed at retail stores, do not list almond.
Chef Mitch Maier's Black Garlic Sauce. Net Wt. 16 oz. (473g). UPC 8 60248-00253 8.
Out of the Kitchen
Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.
Chef Mitch Maier's Black Garlic BBQ Sauce. Net Wt. 19 oz. (538g). UPC 8 60248-00251 4.
Out of the Kitchen
Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.