Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Minimum severity
Vortex Surgical Inc. is recalling Volk Single Use Vitrectomy Lenses due to voids in Tyvek pouch seals that could compromise the sterile barrier and lead to infection.
Olympus is recalling Single Use 3-Lumen Sphincterotomes that may deform if not properly thermoformed during manufacturing, potentially losing performance during use. No illnesses have been reported.
Olympus recalls 1,504 Single Use Sphincterotome V devices due to incomplete thermoforming. Affected devices could deform and lose performance during surgical use.
Olympus is recalling 1,474 units of the Single Use 3-Lumen Sphincterotome V distributed outside the US. Some devices may not have undergone proper thermoforming, which could cause deformation and performance loss.
VANTIVE US HEALTHCARE LLC is recalling 137,576 Prismaflex M150 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit. No injuries have been reported.
VANTIVE's PRIMSAFLEX M100 dialyzer sets may have a deaeration chamber that could dislodge from the control unit. Approximately 230,596 units distributed nationwide are affected.
Vortex Surgical laser probes are recalled for voids in sterilization pouches that compromise sterility and could allow bioburden contamination leading to infection. Multiple probe models are affected across the US and internationally.
Olympus Corporation is recalling Single Use 3-Lumen Sphincterotome V devices (Model KD-VC411Q-0320) because some units did not undergo proper thermoforming and could deform or lose performance during use.
Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.
Olympus is recalling Single Use 3-Lumen Sphincterotome V instruments (Model KD-V411M-3020) because some devices may not have undergone proper thermoforming, causing potential deformation and performance loss. The recall affects 650 units.
Olympus Corporation is recalling approximately 2,344 Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects that could cause deformation and loss of surgical performance.
Vortex Surgical is recalling surgical backflush needles due to voids in Tyvek pouch seals that compromise the sterile barrier. The defect could allow bioburden contamination leading to infection risk.
A software timing issue in MiniMed 780G insulin pumps (software version 6.60) may trigger pump errors that suspend insulin delivery. 577 units are affected, distributed in the US and Israel.
Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.
VANTIVE US HEALTHCARE is recalling 115,112 PRISMAFLEX HF1000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
A lot of Tornier surgical screws is labeled as 5.0mm x 18mm but actually measures 5.0mm x 14mm. If undetected during surgery, the incorrect screw could increase the risk of mechanical failure and require revision surgery.
Vortex Surgical is recalling the TID Pharos Illuminated Depressor (VS0801B) voluntarily. The specific reason is not provided in the available source material. The recall affects 14,789 units distributed in the US and internationally.
Siemens Medical Solutions is recalling three software applications from NAEOTOM Alpha.Pro CT systems. The applications—syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT ASPECTS—have not received FDA 510(k) clearance.
SunMed Holdings is recalling the Broselow Domestic Complete ALS Organizer due to potentially harmful dosing errors for three critical medications used in pediatric emergency care. Vecuronium, Flumazenil, and Ketamine dosages may be incorrect on the reference tool.
The Broselow Pediatric Emergency Tape contains dosing errors for emergency medications including Vecuronium, Flumazenil, and Ketamine, potentially affecting pediatric emergency care calculations.
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to potentially harmful dosing errors for critical emergency medications used in pediatric care.
SunMed Holdings is recalling the Broselow Organizer due to potentially harmful dosing errors for pediatric emergency medications Vecuronium, Flumazenil, and Ketamine. Approximately 89 units have been distributed worldwide.
The FDA is recalling Genesis Push-In Suture Anchors due to reported device failures including anchor breakage, bending, and pull-out. Approximately 200 units were distributed in California and Puerto Rico.
Philips Ingenia Ambition S MR systems with software versions R11.1 or R12.1 may display incorrect tissue stiffness values when viewing MR Elastography data on PACS. Incorrect values could affect clinical interpretation.
A Siemens fluoroscopic X-ray system software issue may prevent ortho images from flipping and could display a previous patient's image. The recall affects 41 units distributed in the US and several other countries.