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 the agency’s own highest classification or reported deaths or serious injuries, 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

6651–6675 of 114917

HighFDA (Devices)·Z-0524-2026·2025-11-26
Gynecology and robotic kits recalled over smoke pencils that may self activate
Medline is recalling 2,844 gynecology laparoscopy and robotic 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) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF…
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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2026·2025-11-26
Oncology software recalled because appended medication orders may mismatch the schedule
Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.
Product
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3…
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-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…
Category
Medical Device
Distribution
Distributed nationwide
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…
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…
Category
Medical Device
Distribution
6 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-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)…
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·26122·2025-11-26
Children's bicycle helmets recalled for failing positional stability and coverage requirements
About 24,300 Outdoor Master children's and youth helmets are being recalled because they do not comply with the mandatory positional stability and coverage requirements.
Product
Outdoor Master Children's and Youth Helmets
Category
Consumer Product
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-0527-2026·2025-11-26
Gynecology surgery kits recalled over smoke pencils that may activate
Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2026·2025-11-26
Basin packs recalled over smoke pencils that may activate unprompted
Medline is recalling 1,921 basin 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) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0545-2026·2025-11-26
Red serum separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 50,050 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0160-2026·2025-11-26
No rinse wash cream recalled over contamination found at the manufacturing facility
DermaRite Industries is recalling 3,178 bottles of 4-N-1 Skin Protectant No Rinse Wash Cream because it was made at the same facility where other products were found contaminated.
Product
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2026·2025-11-26
Serum separator microtubes recalled over unvalidated manufacturing processes
ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2026·2025-11-26
Sodium heparin blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 160,250 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0535-2026·2025-11-26
Shoulder reamers recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Adjustable Angle rTSA Reamer, 42mm, because it was released before design updates and performance testing were completed.
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0557-2026·2025-11-26
Blood gas capillary tubes recalled over an inadequate quality system
ASP Global is recalling 397,000 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres, because they were manufactured under an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0554-2026·2025-11-26
Amber clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0177-2026·2025-11-26
Antiperspirant spray recalled over contamination found elsewhere at the facility
DermaRite Industries is recalling 37,379 spray bottles of UltraSure Anti-Perspirant & Deodorant because it was made at the same facility where other products were found contaminated.
Product
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2026·2025-11-26
Capillary magnetic rings recalled over unvalidated manufacturing processes
ASP Global is recalling 16,920 SAFE-T-FILL magnetic rings for blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0169-2026·2025-11-26
Dry skin therapy cream recalled over contamination found at the facility
DermaRite Industries is recalling 8,378 containers of Lantiseptic Dry Skin Therapy because it was made at the same facility where other products were found contaminated.
Product
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0539-2026·2025-11-26
Clotting time cartridges recalled over dried blood on carton labels
Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0566-2026·2025-11-26
Capillary mixing fleas recalled over an inadequate quality system
ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Category
Medical Device
Distribution
Distributed nationwide

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6651–6675 of 114917