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

151–175 of 390

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-2070-2026·2026-05-13
DEX Ophthalmic Tissue Forceps subject to IFU corrective action
Katalyst Surgical is issuing a field safety corrective action for instructions for use (IFU) in DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH (Model DVF4005-25).
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
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-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-2052-2026·2026-05-13
Spacelabs SL Command Module patient monitor recall due to manufacturing defect
Spacelabs Healthcare is recalling 57 SL Command Module (Model 91496) patient monitoring devices due to a manufacturing issue with the electrical leakage tester that could affect device safety and performance.
Product
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all b
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-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-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-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-2078-2026·2026-05-13
DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall
Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.
Product
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Category
Medical Device
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 (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-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
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-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-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-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 (Devices)·Z-2112-2026·2026-05-13
Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTO
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-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-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-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-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
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-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

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