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

1351–1375 of 27346

HighFDA (Devices)·Z-1307-2026·2026-02-11
Amyloid plasma controls recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 179 units of Lumipulse beta-Amyloid Plasma Controls because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-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-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-1250-2026·2026-02-11
Internal delivery devices 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 25GA I.D.D. Internal Delivery Device, VS0250.25
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-1305-2026·2026-02-11
Amyloid 1-42-N plasma cartridges recalled over falsely elevated results
Fujirebio Diagnostics is recalling 1,423 units of Lumipulse G beta-Amyloid 1-42-N Plasma Immunoreaction Cartridges because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-1244-2026·2026-02-11
Single use vitrectomy lenses 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
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2026·2026-02-11
Ovulation test devices recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the LH One Step Ovulation Test Device (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
LH One Step Ovulation Test Device (Urine)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2026·2026-02-11
Prostate imaging software recalled over accessories that may fail on Windows 10
Focalyx Technologies is recalling 18 units of Focalyx Fusion because accessories may not function properly with Windows 10, which may cause patient harm during biopsy or delay treatment.
Product
Focalyx Fusion
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-1248-2026·2026-02-11
Subretinal injection cannulas 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
25GA Subretinal Injection Cannula VS0220.25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2026·2026-02-11
Surgical laser probes 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 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
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-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
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-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-1262-2026·2026-02-11
Home male fertility tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units covering the Male Fertility Sperm Test for Home Use (Cassette) because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Male Fertility Sperm Test for Home Use (Cassette)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2026·2026-02-11
Menopause test cassettes recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 1,000 units of the Menopause Test Cassette (Urine) because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Menopause Test Cassette (Urine)
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-1263-2026·2026-02-11
Exploro fertility tests recalled over missing FDA premarket clearance
Changchun Wancheng Bio-Electron is recalling 4,800 units of the Exploro Highly Sensitive Male Fertility / Sperm Concentration Test because tests requiring a 510(k) were distributed before they could be legally marketed.
Product
Exploro Highly Sensitive Male Fertility / Sperm Concentration 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-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-1222-2026·2026-02-11
Electrosurgical knives recalled over tip breakage from overheating and burning
Olympus is recalling the Single Use Electrosurgical Knife KD-640L because deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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-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

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1351–1375 of 27346