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

1751–1775 of 27346

HighFDA (Devices)·Z-0521-2026·2025-11-26
General surgery and knee kits recalled over smoke pencil activation defect
Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2026·2025-11-26
Circumcision packs recalled over smoke pencils that may activate unprompted
Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2026·2025-11-26
Bone void implants recalled over an incorrect product name on packaging
Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0513-2026·2025-11-26
Vascular and open heart kits recalled over smoke pencils that may activate
Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0569-2026·2025-11-26
Group B strep test kits recalled over buffer caps missing gaskets
Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
Product
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-0514-2026·2025-11-26
Central line and flap packs recalled over smoke pencils that may activate
Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0509-2026·2025-11-26
ECMO consoles recalled after eleven reports of a blank touchscreen error
Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.
Product
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2026·2025-11-26
Flow cytometers recalled over software that crashes during sample acquisition
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0572-2026·2025-11-26
Nephrostomy balloon kits recalled after containing the wrong sized catheter
Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.
Product
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter attached
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0574-2026·2025-11-26
Reprocessed imaging catheters recalled after exceeding validated reprocessing cycles
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
Product
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR US
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0542-2026·2025-11-26
Cell morphology analyzers recalled over barcodes read from the previous slide
Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.
Product
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2026·2025-11-26
Major vaginal surgery packs recalled over smoke pencil activation defect
Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0518-2026·2025-11-26
Port insertion packs recalled over smoke pencils that may stay live
Medline is recalling 12 Port Insertion Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0506-2026·2025-11-26
Heart pump controllers recalled over corrosion at the backup battery connector
Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2026·2025-11-26
Breast biopsy packs recalled over smoke pencils that may activate
Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2026·2025-11-26
Luer tip caps recalled after trays failed routine biocompatibility testing
Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.
Product
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2026·2025-11-26
LEEP procedure packs recalled over smoke pencils that may self activate
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0530-2026·2025-11-26
Neuro and joint kits recalled over smoke pencils that may activate
Medline is recalling 40,151 neurosurgery, back and joint convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2026·2025-11-26
Hemostasis valves recalled because the valve cap may remain depressed
Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.
Product
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-0508-2026·2025-11-26
HeartMate II controllers recalled over corrosion at the battery connector
Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2026·2025-11-26
Heart pump implant kits recalled over corrosion at the battery connector
Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2026·2025-11-26
Minor eye trays recalled over smoke pencils that may stay active
Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0505-2026·2025-11-26
Heart pump kits recalled over corrosion at the backup battery connector
Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Product
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0511-2026·2025-11-26
Local basic kits recalled over smoke pencils that may stay active
Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2026·2025-11-26
Neuro shunt and laminectomy kits recalled over smoke pencil activation defect
Medline is recalling 1,315 neurosurgery convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; 2) ACDF CDS, REF CDS941061M; 3) NEURO PACK-LF, REF DYNJ0038440C; 4) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925S; 5) NEURO-ORTHO EXTRAS, REF DYNJ44882M; 6) LAMINECTOMY, REF DYNJ903870F.
Category
Medical Device
Distribution
Distributed nationwide

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1751–1775 of 27346