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

926–950 of 13390

HighFDA (Devices)·Z-1304-2026·2026-02-11
[pending] Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not
Pending LLM rewrite. Source: FDA_DEVICE Z-1304-2026.
Product
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2026·2026-02-11
[pending] Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Cata
Pending LLM rewrite. Source: FDA_DEVICE Z-1311-2026.
Product
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1271-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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 current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1273-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1273-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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 current.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1226-2026·2026-02-11
[pending] OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Pending LLM rewrite. Source: FDA_DEVICE Z-1226-2026.
Product
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1262-2026·2026-02-11
[pending] Male Fertility Sperm Test for Home Use (Cassette)
Pending LLM rewrite. Source: FDA_DEVICE Z-1262-2026.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2026·2026-02-11
[pending] VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam
Pending LLM rewrite. Source: FDA_DEVICE Z-1236-2026.
Product
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 42364
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2026·2026-02-11
[pending] Vivoo Vaginal pH Test
Pending LLM rewrite. Source: FDA_DEVICE Z-1266-2026.
Product
Vivoo Vaginal pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1263-2026·2026-02-11
[pending] Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Pending LLM rewrite. Source: FDA_DEVICE Z-1263-2026.
Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1289-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1289-2026.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 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-1296-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Desc
Pending LLM rewrite. Source: FDA_DEVICE Z-1296-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 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
[pending] Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3)
Pending LLM rewrite. Source: FDA_DEVICE Z-1308-2026.
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-1303-2026·2026-02-11
[pending] Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version
Pending LLM rewrite. Source: FDA_DEVICE Z-1303-2026.
Product
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration cu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1270-2026.
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-1161-2026·2026-02-11
[pending] HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00
Pending LLM rewrite. Source: FDA_DEVICE Z-1161-2026.
Product
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1288-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1288-2026.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-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-1297-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1297-2026.
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-1158-2026·2026-02-11
[pending] AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M0055
Pending LLM rewrite. Source: FDA_DEVICE Z-1158-2026.
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2026·2026-02-11
[pending] Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product De
Pending LLM rewrite. Source: FDA_DEVICE Z-1286-2026.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 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-1227-2026·2026-02-11
[pending] PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysa
Pending LLM rewrite. Source: FDA_DEVICE Z-1227-2026.
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-1278-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC4
Pending LLM rewrite. Source: FDA_DEVICE Z-1278-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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-1243-2026·2026-02-11
[pending] Focalyx Fusion
Pending LLM rewrite. Source: FDA_DEVICE Z-1243-2026.
Product
Focalyx Fusion
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2026·2026-02-11
[pending] PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed D
Pending LLM rewrite. Source: FDA_DEVICE Z-1224-2026.
Product
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1275-2026·2026-02-11
[pending] Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software V
Pending LLM rewrite. Source: FDA_DEVICE Z-1275-2026.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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-1245-2026·2026-02-11
[pending] Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat
Pending LLM rewrite. Source: FDA_DEVICE Z-1245-2026.
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

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926–950 of 13390