HighFDA (Devices)·Z-1265-2026·2026-02-11
[pending] Vivoo Protein Test
Pending LLM rewrite. Source: FDA_DEVICE Z-1265-2026.
- Product
- Vivoo Protein Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
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.
Filters
Minimum severity
951–975 of 13390
- HighFDA (Devices)·Z-1299-2026·2026-02-11
[pending] FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
Pending LLM rewrite. Source: FDA_DEVICE Z-1299-2026.
- Product
- FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1277-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC
Pending LLM rewrite. Source: FDA_DEVICE Z-1277-2026.
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1163-2026·2026-02-11
[pending] *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN):
Pending LLM rewrite. Source: FDA_DEVICE Z-1163-2026.
- Product
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1228-2026·2026-02-11
[pending] PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysa
Pending LLM rewrite. Source: FDA_DEVICE Z-1228-2026.
- 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-1254-2026·2026-02-11
[pending] Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Pending LLM rewrite. Source: FDA_DEVICE Z-1254-2026.
- Product
- Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1285-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1285-2026.
- Product
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-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-1268-2026·2026-02-11
[pending] Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V
Pending LLM rewrite. Source: FDA_DEVICE Z-1268-2026.
- 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-1252-2026·2026-02-11
[pending] Vortex Surgical I2 Injection Kit, VS0500
Pending LLM rewrite. Source: FDA_DEVICE Z-1252-2026.
- Product
- Vortex Surgical I2 Injection Kit, VS0500
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1284-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC43
Pending LLM rewrite. Source: FDA_DEVICE Z-1284-2026.
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-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 c
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1255-2026·2026-02-11
[pending] Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Pending LLM rewrite. Source: FDA_DEVICE Z-1255-2026.
- Product
- Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1231-2026·2026-02-11
[pending] PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dial
Pending LLM rewrite. Source: FDA_DEVICE Z-1231-2026.
- Product
- PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1279-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1279-2026.
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1274-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1274-2026.
- Product
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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-1229-2026·2026-02-11
[pending] PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialy
Pending LLM rewrite. Source: FDA_DEVICE Z-1229-2026.
- Product
- PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1242-2026·2026-02-11
[pending] NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdens
Pending LLM rewrite. Source: FDA_DEVICE Z-1242-2026.
- Product
- NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1233-2026·2026-02-11
[pending] EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Pending LLM rewrite. Source: FDA_DEVICE Z-1233-2026.
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Category
- Medical Device
- Distribution
- 14 states
- HighFDA (Devices)·Z-1257-2026·2026-02-11
[pending] LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS;
Pending LLM rewrite. Source: FDA_DEVICE Z-1257-2026.
- Product
- LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1280-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1280-2026.
- 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-1239-2026·2026-02-11
[pending] SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensiti
Pending LLM rewrite. Source: FDA_DEVICE Z-1239-2026.
- Product
- SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1159-2026·2026-02-11
[pending] AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M005536
Pending LLM rewrite. Source: FDA_DEVICE Z-1159-2026.
- Product
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1222-2026·2026-02-11
[pending] Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife
Pending LLM rewrite. Source: FDA_DEVICE Z-1222-2026.
- Product
- Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electr
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1292-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1292-2026.
- 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-1225-2026·2026-02-11
[pending] PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed D
Pending LLM rewrite. Source: FDA_DEVICE Z-1225-2026.
- Product
- PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-1261-2026·2026-02-11
[pending] S. Typhi/Para Typhi A Antigen
Pending LLM rewrite. Source: FDA_DEVICE Z-1261-2026.
- Product
- S. Typhi/Para Typhi A Antigen
- Category
- Medical Device
- Distribution
- Distributed nationwide