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.

Agency

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

2351–2375 of 30649

HighFDA (Devices)·Z-1290-2026·2026-02-11
Sphincterotome V surgical instruments recalled for potential deformation
Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V devices due to a manufacturing defect where some units may have failed thermoforming, potentially causing deformation and loss of performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 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-1270-2026·2026-02-11
Olympus Disposable Triple Lumen Sphincterotome Recall Due to Deformation Risk
Olympus recalls Disposable Triple Lumen Sphincterotomes due to incomplete thermoforming that could cause device deformation and loss of performance. Affected units may not function properly during papillotomy procedures.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 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-1308-2026·2026-02-11
Molift Mover 205 patient lift devices recalled due to structural bolt failure
ETAC A/S is recalling 95 Molift Mover 205 patient lift devices due to a defective mounting bolt that can break and cause material deformation, limiting joint mobility and device functionality.
Product
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2026·2026-02-11
Molift 2-Point Sling Bars Recalled for Structural Bolt Failure
ETAC A/S is recalling Molift 2-point sling bars due to bolts breaking during assembly and testing. The defect causes material deformation that prevents proper functionality in this assistive device.
Product
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
Category
Medical Device
Distribution
Distributed nationwide
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
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
ModerateFDA (Food)·H-0465-2026·2026-02-11
Organic Spices Sumac Recalled for Mislabeling and False 'No Salt' Claim
Spicely organic sumac is recalled because the product contains salt as an ingredient but displays 'NO SALT' claims on the packaging. 980 cases distributed across 13 U.S. states.
Product
spicely ORGANIC sumac NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 2oz (56g) Ingredients: Organic Sumac, Salt www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007339
Category
Food
Distribution
13 states
ModerateFDA (Drugs)·D-0342-2026·2026-02-11
Prescription Diclofenac Sodium Topical Gel Recalled for Viscosity Specification Failure
SUN PHARMACEUTICAL is recalling Diclofenac Sodium Topical Gel (3% in 100 g tubes) due to viscosity specification failure. Lot AD92721 (expires 3/31/2027) was distributed nationwide.
Product
DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0441-2026·2026-02-11
Lost and Found Energy Drink Recalled for Caffeine Content Labeling Error
Lost and Found Energy drinks are being recalled due to a labeling error that understates caffeine content. The product contains 300mg of caffeine per can but the label indicates 150mg.
Product
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Category
Food
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 (Food)·H-0463-2026·2026-02-11
Spicely Organic Garlic Salt Mislabeled as Salt-Free
Organic Spices, Inc. is recalling spicely Organic garlic salt because the product contains salt but is labeled as salt-free. The affected product was distributed across 13 U.S. states.
Product
spicely ORGANIC garlic salt NO ARTIFICIAL COLORING NO GLUTEN - NO MSG - NO SOY NO PRESERVATIVES - NO WHEAT NO SUGAR - NO SALT - NO IRRADIATION Net wt: 3.4oz (96g) Ingredients: Salt, *Garlic *Organic www.spicely.com Organic Spices Inc, Fremont CA 94538 UPC: 826998007643
Category
Food
Distribution
13 states
ModerateFDA (Food)·H-0446-2026·2026-02-11
BarbaCuban Ram Air Red Zesty Ketchup Recalled for Undeclared Quinine
BarbaCuban Ram Air Red Zesty Ketchup is being recalled due to undeclared quinine. The voluntary recall affects 12,214 bottles distributed in Florida.
Product
BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7
Category
Food
Distribution
0 states
ModerateFDA (Food)·H-0448-2026·2026-02-11
BarbaCuban Havana Gold beverage recalled for undeclared quinine
Prima Foods International is recalling BarbaCuban Havana Gold beverage distributed in Florida because it contains undeclared quinine. The recall affects 12,214 bottles with lot code #233/24 and best-by date February 2026.
Product
BarbaCuban Havana Gold, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles. UPC code 7 19660 00097 7
Category
Food
Distribution
0 states
ModerateFDA (Food)·H-0445-2026·2026-02-11
Hot sauce recalled for undeclared quinine ingredient
Prima Foods International is recalling BarbaCuban 455 Everything Sauce (Hot) due to undeclared quinine. The recall affects bottles distributed in Florida with lot codes #190/24 and #339/24.
Product
BarbaCuban 455 Everything Sauce (Hot), Net Wt 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00083 0
Category
Food
Distribution
0 states
ModerateFDA (Food)·H-0443-2026·2026-02-11
Sauce Company Recalls Product Over Undeclared Quinine Ingredient
Prima Foods International recalls BarbaCuban 455 Everything Sauce because the product contains quinine that was not declared on the label. The recall affects 12,214 bottles distributed in Florida.
Product
BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Ke
Category
Food
Distribution
0 states
LowFDA (Food)·H-0442-2026·2026-02-11
OptiWize Collagen Plus Supplement Recalled for Labeling Discrepancy
OptiWize Inc. is recalling OptiWize Collagen Plus supplements after NSF testing found that the manganese level did not match what was stated on the label.
Product
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·24V717000·2026-02-09
2025 Brinkley RV Model Z Travel Trailer Safety Chain Recall
Brinkley is recalling certain 2025 Model Z travel trailers with underrated safety chains. The chains can break, allowing the trailer to detach and increasing the risk of a crash.
Product
BRINKLEY RV — 2025 BRINKLEY RV MODEL Z
Category
Vehicle
Distribution
Distributed nationwide

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