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

951–975 of 39760

HighFDA (Devices)·Z-2102-2026·2026-05-13
Medline Convenience Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.
Product
Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A; 4) TOTE SB NGUYEN CAPSULOTOMY, Model Number: DYKM1756A; 5) TOTE MOMENI SB CAPSULOTOMY REC, Mode
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2026·2026-05-13
Medline Convenience Kits recalled for potential sterilization compromise
Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number:DYNJ56436B; 3) SCC RF PAIN MGMT, Model Number:DYNJ56436C; 4) CPNB SETUP TRAY, Model Number:DYNJRA1979; 5) CPNB SETUP TRAY, Model Number:DYNJRA1979A; 6) CPNB SETUP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2026·2026-05-13
Medline Medical Device Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
Product
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326A; 3) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326B; 4) DRAWER #5, Model Number: ACC010475; 5) DRAWER 1 NEURO CAR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2121-2026·2026-05-13
Medline Convenience Kits General Closure sterilization calibration issue
Medline Industries is recalling Convenience Kits (Model DYKMBNDL200A) due to calibration issues in sterilization equipment that may have compromised sterility assurance. The kits were distributed nationwide.
Product
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2051-2026·2026-05-13
Prodisc C SK cervical disc implant labeling mix-up recalled
Centinel Spine is recalling Prodisc C SK U.S. Implant Extra Large cervical disc replacement devices due to a labeling mix-up where 6mm implants were labeled as 5mm and 5mm implants were labeled as 6mm.
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2026·2026-05-13
Medline Cardiac Surgery Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling cardiac surgery convenience kits because sterilization and packaging equipment calibration issues may have affected the sterility assurance level of the devices.
Product
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2026·2026-05-13
One Step P in vitro diagnostic test lacks FDA premarket clearance
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
Product
One Step P in vitro diagnostic test REF: 8194
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2117-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2126-2026·2026-05-13
Medline Urology Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling five models of urology convenience kits due to calibration issues in sterilization and packaging equipment that may compromise sterility assurance.
Product
Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2073-2026·2026-05-13
DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.
Product
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2082-2026·2026-05-13
One Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
DFI Co., Ltd. is recalling the One Step 10A in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval. The recall affects 6533 units distributed nationwide in Florida, Pennsylvania, and England.
Product
One Step 10A in vitro diagnostic test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2099-2026·2026-05-13
Medline Convenience Kits Recalled for Potential Sterilization Calibration Issues
Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.
Product
See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2105-2026·2026-05-13
Medline Admit Kit DYKA1343A Medical Device Recall
Medline is recalling Admit Kits (Model DYKA1343A) due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2026·2026-05-13
Medline Convenience Kits sterilization calibration issue recalled
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2075-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Field Safety Corrective Action Notice
Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2100-2026·2026-05-13
Medline Convenience Kits surgical packs sterilization calibration recall
Medline Industries is recalling three models of surgical convenience kits—Lithotomy Packs and Lap Basin—due to calibration issues with sterilization equipment that could affect the sterility assurance of the products.
Product
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2026·2026-05-13
Medline Surgical Gowns Sterilization Calibration Issues
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Product
See complete list in RES, exceeds character limit. Medline Surgical Gowns
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2026·2026-05-13
QUCARE Total Cholesterol in vitro Diagnostic Test Recalled
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
Product
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2130-2026·2026-05-13
Medline Surgical Packs recalled due to sterilization equipment calibration issues
Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2120-2026·2026-05-13
Medline Burn Care Kits Recalled Due to Sterilization Calibration Issues
Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.
Product
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2111-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.
Product
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2079-2026·2026-05-13
DEX Ophthalmic Tissue Forceps recalled for instructions update
Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2080-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Model DVF4034-27 Medical Device Recall
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.
Product
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2083-2026·2026-05-13
One Step UTI in vitro diagnostic test recalled for missing FDA approval
DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.
Product
One Step UTI in vitro diagnostic test REF: 3374
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2026·2026-05-13
One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
Product
One Step pH in vitro diagnostic test REF: 31I4P
Category
Medical Device
Distribution
Distributed nationwide

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951–975 of 39760