Recalls

All US Product 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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1076–1100 of 13464

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
HighFDA (Devices)·Z-1209-2026·2026-02-04
MR Imaging System May Display Incorrect Stiffness Values
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.
Product
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1174-2026·2026-02-04
X-Ray Imaging System Ortho Images Not Flipped; Possible Display of Previous Patient Images
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.
Product
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1204-2026·2026-02-04
Philips Evolution Upgrade 1.5T MR Systems May Display Inaccurate Elastography Values
Philips Evolution Upgrade 1.5T MR systems may display inaccurate stiffness values from MR Elastography scans when viewed in PACS, potentially affecting clinical interpretation.
Product
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2026·2026-02-04
Fixone Biocomposite Anchor Recalled for Device Failure Reports
Aju Pharm Co., Ltd. is recalling 1,088 units of the Fixone Biocomposite Anchor due to reports of device failures including breakage, bending, and pullout. No injuries have been reported.
Product
Fixone Biocomposite Anchor
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1220-2026·2026-02-04
BEAR Implant Model 1000 recalled for incorrect expiration date labeling
Miach Orthopaedics is recalling 284 units of the BEAR Implant Model 1000 due to an incorrect expiration date on the label that extends beyond the product's documented shelf life. The incorrect label date also makes the UDI incorrect.
Product
BEAR Implant. Model Number: 1000.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1194-2026·2026-02-04
Medline HEAD SHAVE-LATEX SAFE KIT recalled for cracking tubing defect
Medline HEAD SHAVE-LATEX SAFE KIT kits are being recalled due to complaints that the MASTISOL liquid adhesive tubing cracks during use, potentially causing adhesive leakage.
Product
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2026·2026-02-04
Medline Medical Procedure Convenience Kits Recalled for Cracking Tubing Defect
Medline medical procedure convenience kits containing MASTISOL liquid adhesive are recalled due to reports that the butyrate tubing in the adhesive vials cracks during use. Approximately 857 units were distributed nationwide.
Product
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2026·2026-02-04
Ingenia 3.0T Magnetic Resonance Systems Stiffness Value Display Errors Recalled
Philips is recalling Ingenia 3.0T MR systems that may display incorrect stiffness values when viewing exported MR Elastography maps in PACS viewers, potentially affecting clinical diagnostic accuracy.
Product
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2026·2026-02-04
Genesis Knotless Anchor Devices Recalled Due to Reported Breakage and Failure
Aju Pharm Co., Ltd. is recalling Genesis Knotless Anchor surgical devices due to reports of device failure, including anchor breakage, bending, and pullout. The recall affects 1,163 units distributed in California and Puerto Rico.
Product
Genesis Knotless Anchor
Category
Medical Device
Distribution
Distributed nationwide

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1076–1100 of 13464