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

1801–1825 of 39948

HighFDA (Devices)·Z-1306-2026·2026-02-11
Amyloid 1-42-N plasma calibrators recalled over falsely elevated results
Fujirebio Diagnostics is recalling 128 units of Lumipulse G beta-Amyloid 1-42-N Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-1232-2026·2026-02-11
Surgical robots recalled over a software error hiding failed arm diagnostics
Intuitive Surgical is recalling 219 da Vinci X, Xi and da Vinci 5 systems because a software error allowed instrument arms failing an important diagnostic test to remain in clinical use.
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-1236-2026·2026-02-11
Susceptibility test cards recalled over false resistant antibiotic results
bioMerieux is recalling 2,668,954 VITEK 2 Gram-negative Susceptibility Cards over a potential risk of quality control failures and false resistant antibiotic results.
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-1258-2026·2026-02-11
Ketone and urinalysis strips recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
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-1257-2026·2026-02-11
Urinalysis test strips recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 91,366 units of LotFancy Urinary Tract Infection Urine (UTI) Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
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-1238-2026·2026-02-11
Insulin pumps recalled over errors that suspend insulin delivery
Medtronic MiniMed is recalling 577 MiniMed 780G insulin pumps on software version 6.60 because a timing and processor communication issue may trigger Pump Error 43 or 41, suspending insulin delivery.
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-1267-2026·2026-02-11
Vivoo sodium and hydration tests recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,300 units of Vivoo Sodium Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2026·2026-02-11
Acetabular liners recalled over packages containing the wrong component
Encore Medical is recalling 49 EMPOWR acetabular system liners after a package labeled 942-01-40G was found to contain a 942-01-36H liner.
Product
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1301-2026·2026-02-11
Plasma ratio test recalled over falsely elevated amyloid classification results
Fujirebio Diagnostics is recalling 23 units of Lumipulse G pTau217/beta-Amyloid 1-42 Plasma Ratio because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-1253-2026·2026-02-11
Diamond dusted ILM elevators recalled over voids in pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1266-2026·2026-02-11
Vaginal pH tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 3,000 units of Vivoo Vaginal pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo Vaginal pH Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2026·2026-02-11
Scleral IOL markers recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1249-2026·2026-02-11
Vitrectomy convenience kits recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1251-2026·2026-02-11
Retractable membrane polishers recalled over voids in sterile pouch seals
Vortex Surgical is recalling 14,789 units because there may be voids in the seal of the Tyvek pouches, which compromises the sterile barrier.
Product
Tecfen Retractable Membrane Polisher, QTPR1267-23
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2026·2026-02-11
pTau 217 plasma cartridges recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
Product
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1304-2026·2026-02-11
pTau 217 plasma controls recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 148 units of Lumipulse pTau 217 Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-1237-2026·2026-02-11
Peripheral screws recalled after a lot was labeled the wrong length
Tornier is recalling 427 Perform Reversed peripheral screws because a lot labeled 5.0mm x 18mm actually contains 5.00mm x 14mm screws.
Product
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1233-2026·2026-02-11
Knee tibial inserts recalled over a possible packaging discrepancy
Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1261-2026·2026-02-11
Typhoid antigen tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the S. Typhi/Para Typhi A Antigen test because it was distributed before it could be legally marketed.
Product
S. Typhi/Para Typhi A Antigen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1265-2026·2026-02-11
Vivoo protein tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo Protein Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo Protein Test
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1264-2026·2026-02-11
Vivoo pH tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 500 units of the Vivoo pH Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Vivoo pH Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1239-2026·2026-02-11
SOMATOM X.ceed software applications recalled over missing FDA clearance
Siemens is removing three software applications from two SOMATOM X.ceed CT systems because the applications have not received FDA 510(k) clearance.
Product
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
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-1274-2026·2026-02-11
Sphincterotome KD-V411M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-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-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
ModerateFDA (Devices)·Z-1226-2026·2026-02-11
Oxiris sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 2,724 Oxiris Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide

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1801–1825 of 39948