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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

776–800 of 30631

ModerateFDA (Devices)·Z-2071-2026·2026-05-13
DEX Ophthalmic Tissue Forceps instructions for use correction
Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
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-2074-2026·2026-05-13
DEX Ophthalmic Tissue Forceps recalled for instruction updates
Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0516-2026·2026-05-13
Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity
Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.
Product
DULOXETINE — DULOXETINE (DULOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2026·2026-05-13
Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.
Product
DULOXETINE — DULOXETINE (DULOXETINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2069-2026·2026-05-13
DEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action
Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.
Product
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0520-2026·2026-05-13
Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities
JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.
Product
ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
Category
Drug
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 (Drugs)·D-0522-2026·2026-05-13
Duloxetine delayed-release capsules recalled for N-nitroso impurity contamination
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
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-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-2132-2026·2026-05-13
ZENBONE Resorbable Bone Void Filler Recall Outside Specifications
Orthorebirth Co Ltd is recalling ZENBONE resorbable bone void filler because the product falls outside standard specifications. The recall affects specific lot numbers distributed nationwide in California and Florida.
Product
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
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-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-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-2086-2026·2026-05-13
Uric Acid in vitro diagnostic test distributed without FDA clearance
DFI Co., Ltd. is recalling its Uric Acid in vitro diagnostic test (REF: 31H0P) because the devices were distributed without required FDA premarket clearance or approval.
Product
Uric Acid in vitro diagnostic test REF: 31H0P
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-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-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-2115-2026·2026-05-13
Medline Tracheostomy Convenience Kits Sterilization Calibration Recall
Medline Industries is recalling certain tracheostomy convenience kits and related products due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2087-2026·2026-05-13
One Step K in vitro diagnostic test recall for missing FDA clearance
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
Product
One Step K in vitro diagnostic test REF: 81A4
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-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-2077-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Require Corrective Instructions Update
Katalyst Surgical is correcting instructions for DEX Ophthalmic Tissue Forceps (Model DVF4022-25-S) due to a field safety issue related to the Instructions for Use (IFU).
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Category
Medical Device
Distribution
Distributed nationwide

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