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

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976–1000 of 13390

HighFDA (Devices)·Z-1223-2026·2026-02-11
[pending] Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgica
Pending LLM rewrite. Source: FDA_DEVICE Z-1223-2026.
Product
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1301-2026·2026-02-11
[pending] Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Softwar
Pending LLM rewrite. Source: FDA_DEVICE Z-1301-2026.
Product
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1295-2026.
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-1307-2026·2026-02-11
[pending] Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: No
Pending LLM rewrite. Source: FDA_DEVICE Z-1307-2026.
Product
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1246-2026·2026-02-11
[pending] Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK
Pending LLM rewrite. Source: FDA_DEVICE Z-1246-2026.
Product
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2026·2026-02-11
[pending] MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The Mi
Pending LLM rewrite. Source: FDA_DEVICE Z-1238-2026.
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-1250-2026·2026-02-11
[pending] Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Pending LLM rewrite. Source: FDA_DEVICE Z-1250-2026.
Product
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1276-2026.
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-1281-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1281-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; 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-1305-2026·2026-02-11
[pending] Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 2
Pending LLM rewrite. Source: FDA_DEVICE Z-1305-2026.
Product
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1237-2026·2026-02-11
[pending] TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Pending LLM rewrite. Source: FDA_DEVICE Z-1237-2026.
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1240-2026·2026-02-11
[pending] NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensitie
Pending LLM rewrite. Source: FDA_DEVICE Z-1240-2026.
Product
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1251-2026·2026-02-11
[pending] Tecfen Retractable Membrane Polisher, QTPR1267-23
Pending LLM rewrite. Source: FDA_DEVICE Z-1251-2026.
Product
Tecfen Retractable Membrane Polisher, QTPR1267-23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2026·2026-02-11
[pending] The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Stri
Pending LLM rewrite. Source: FDA_DEVICE Z-1258-2026.
Product
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1293-2026·2026-02-11
[pending] Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphinctero
Pending LLM rewrite. Source: FDA_DEVICE Z-1293-2026.
Product
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1248-2026·2026-02-11
[pending] 25GA Subretinal Injection Cannula VS0220.25
Pending LLM rewrite. Source: FDA_DEVICE Z-1248-2026.
Product
25GA Subretinal Injection Cannula VS0220.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2026·2026-02-11
[pending] Vivoo pH Test
Pending LLM rewrite. Source: FDA_DEVICE Z-1264-2026.
Product
Vivoo pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1282-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; 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-1267-2026·2026-02-11
[pending] Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Pending LLM rewrite. Source: FDA_DEVICE Z-1267-2026.
Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1230-2026·2026-02-11
[pending] PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialy
Pending LLM rewrite. Source: FDA_DEVICE Z-1230-2026.
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-1235-2026·2026-02-11
[pending] CellMek SPS Sample Preparation System, REF: C44603, with software
Pending LLM rewrite. Source: FDA_DEVICE Z-1235-2026.
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1247-2026·2026-02-11
[pending] Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8
Pending LLM rewrite. Source: FDA_DEVICE Z-1247-2026.
Product
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1306-2026·2026-02-11
[pending] Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Softwar
Pending LLM rewrite. Source: FDA_DEVICE Z-1306-2026.
Product
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2026·2026-02-11
[pending] Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720
Pending LLM rewrite. Source: FDA_DEVICE Z-1269-2026.
Product
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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-1291-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1291-2026.
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

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976–1000 of 13390