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

1826–1850 of 39987

ModerateFDA (Devices)·Z-1286-2026·2026-02-11
Sphincterotome KD-411Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1310-2026·2026-02-11
Hoist sling bars recalled after a lifting bar mounting bolt broke
ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
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
ModerateFDA (Devices)·Z-1225-2026·2026-02-11
Prismaflex ST150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 264,040 units of the PRISMAFLEX ST150 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1231-2026·2026-02-11
Prismaflex TPE2000 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2026·2026-02-11
Bubble sensors recalled over connecting cables that can be damaged
Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1224-2026·2026-02-11
Prismaflex ST100 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1270-2026·2026-02-11
Sphincterotome KD-431Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1278-2026·2026-02-11
Distal wire guided sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1280-2026·2026-02-11
Sphincterotome KD-VC411Q-0320 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1296-2026·2026-02-11
Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1241-2026·2026-02-11
CT software applications recalled because they lack FDA clearance
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1291-2026·2026-02-11
Sphincterotome KD-V411M-1530 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-1530, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1276-2026·2026-02-11
Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, because devices which did not undergo thermoforming could 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
ModerateFDA (Devices)·Z-1289-2026·2026-02-11
Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1229-2026·2026-02-11
Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber
Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1221-2026·2026-02-11
Hematology diluents recalled over elevated platelet background check counts
Beckman Coulter is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because specific lots contribute to elevated platelet Daily Checks background counts.
Product
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1275-2026·2026-02-11
Sphincterotome KD-V431M-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0720, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1254-2026·2026-02-11
Illuminated depressors recalled with no reason given in the record
Vortex Surgical is recalling the TID Pharos Illuminated Depressor, VS0801B. The reason field in the enforcement record reads only "XXX", so no hazard is stated.
Product
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1298-2026·2026-02-11
Nasal jejunal feeding tubes recalled without the nasal transfer tube
Wilson-Cook Medical is recalling 60 Nasal Jejunal Feeding Tubes, REF NJFT-10, because they were packaged without the nasal transfer tube component.
Product
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1297-2026·2026-02-11
Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1228-2026·2026-02-11
Prismaflex M150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1269-2026·2026-02-11
Sphincterotome KD-VC431Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
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
ModerateFDA (Devices)·Z-1287-2026·2026-02-11
Sphincterotome KD-401Q-0330 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 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
ModerateFDA (Devices)·Z-1308-2026·2026-02-11
Molift Mover 205 hoists recalled after a mounting bolt broke
ETAC A/S is recalling 95 Molift Mover 205 mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
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
ModerateFDA (Devices)·Z-1311-2026·2026-02-11
Four point sling bars recalled after a mounting bolt broke
ETAC A/S is recalling 25 Molift 4-point sling bars after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
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

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1826–1850 of 39987