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 27375

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-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-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-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-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-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-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-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-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-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-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-1235-2026·2026-02-11
Sample preparation systems recalled over a software dispensing error
Beckman Coulter is recalling 50 CellMek SPS Sample Preparation Systems because a software error dispenses samples close to or touching tube bottoms, removing 60-100 microliters from the final sample.
Product
CellMek SPS Sample Preparation System, REF: C44603, with software
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-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-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-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-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-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-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-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-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-1303-2026·2026-02-11
pTau 217 plasma calibrators recalled over falsely elevated ratio results
Fujirebio Diagnostics is recalling 117 units of Lumipulse G pTau 217 Plasma Calibrators because falsely elevated ratio results can incorrectly classify a patient as having amyloid pathology.
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-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-1299-2026·2026-02-11
X-ray systems recalled over welded contactor contacts that may overheat
FUJIFILM Healthcare Americas is recalling 16 FDR Visionary Suite systems because welded contactor contacts may keep supplying current after the device is switched off.
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-1247-2026·2026-02-11
Disposable forceps and 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
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8
Category
Medical Device
Distribution
Distributed nationwide

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1351–1375 of 27375