Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

1001–1025 of 13399

HighFDA (Devices)·Z-1232-2026·2026-02-11
Robotic surgical systems recalled for undetected arm defects
Intuitive Surgical recalled da Vinci X, Xi, and 5 surgical systems due to a software error that failed to detect bent manipulator arms. The faulty arms pose a risk of failure during surgery.
Product
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinci 5 surgical systems each consist of three main components:
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1291-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss
Olympus is recalling Single Use 3-Lumen Sphincterotome V devices that may not have undergone proper thermoforming, which could cause deformation and performance loss during use.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1244-2026·2026-02-11
Volk Single Use Vitrectomy Lenses Recalled for Compromised Sterile Barrier
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.
Product
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1272-2026·2026-02-11
Olympus Sphincterotome Devices May Deform Due to Manufacturing Defect
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1283-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Manufacturing Defect in Thermoforming Process
Olympus recalls 1,504 Single Use Sphincterotome V devices due to incomplete thermoforming. Affected devices could deform and lose performance during surgical use.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1297-2026·2026-02-11
Olympus Sphincterotome Recall Due to Potential Deformation and Performance Loss
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1228-2026·2026-02-11
Prismaflex M150 dialyzer sets recalled for deaeration chamber dislodgement
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.
Product
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1227-2026·2026-02-11
Dialyzer Deaeration Chamber Potential Dislodgement Prompts Safety Recall
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.
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2026·2026-02-11
Surgical Laser Probes Recalled Due to Compromised Sterile Barrier Seals
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.
Product
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Potential Deformation and Performance Loss
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1268-2026·2026-02-11
Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation
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.
Product
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2026·2026-02-11
FDA Recalls Single Use Sphincterotome Due to Deformation Risk
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2026·2026-02-11
Single Use Sphincterotomes recalled for potential deformation and performance loss
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1255-2026·2026-02-11
Surgical Backflush Needles Recalled for Compromised Sterile Barrier
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.
Product
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2026·2026-02-11
MiniMed 780G Insulin Pump Software Error May Suspend Delivery
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.
Product
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-1276-2026·2026-02-11
Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance
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.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2026·2026-02-11
Dialyzer deaeration chamber may dislodge from control unit
VANTIVE US HEALTHCARE is recalling 115,112 PRISMAFLEX HF1000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Product
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1237-2026·2026-02-11
Surgical screws recalled due to labeling error and size mismatch
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.
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1254-2026·2026-02-11
Surgical Device Recall: Vortex Pharos Illuminated Depressor
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.
Product
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1242-2026·2026-02-11
Siemens recalls three software applications from NAEOTOM Alpha.Pro CT systems
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.
Product
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2026·2026-02-04
Broselow Emergency Organizer Recalled for Pediatric Drug Dosing Errors
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.
Product
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1114-2026·2026-02-04
Broselow Pediatric Emergency Rainbow Tape dosing errors for critical medications
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to potentially harmful dosing errors for critical emergency medications used in pediatric care.
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1115-2026·2026-02-04
Broselow Pediatric Emergency Tape recalled for dosing errors in emergency drugs
The Broselow Pediatric Emergency Tape contains dosing errors for emergency medications including Vecuronium, Flumazenil, and Ketamine, potentially affecting pediatric emergency care calculations.
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1117-2026·2026-02-04
Broselow Organizer Recalled for Potentially Harmful Dosing Errors
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.
Product
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Comp
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1171-2026·2026-02-04
FDA Recalls Genesis Push-In Suture Anchors for Structural Device Failures
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.
Product
Genesis Push-In Suture Anchor
Category
Medical Device
Distribution
Distributed nationwide

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