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

126–150 of 390

HighFDA (Devices)·Z-2046-2026·2026-05-13
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
Intuitive Surgical is recalling certain Universal Surgical Manipulator arm sub-assemblies in da Vinci X and Xi Surgical Systems due to screws that may be susceptible to breaking during use.
Product
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision
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-2124-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of Convenience Kits because calibration problems with sterilization and packaging equipment may have compromised the sterility of the products.
Product
Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2026·2026-05-13
Medline Surgical Drapes Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling multiple models of surgical drapes due to calibration issues with sterilization and packaging equipment that may have compromised the sterility assurance level of the products. All affected units were distributed nationwide.
Product
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2026·2026-05-13
Medline Triple Lumen Insertion Kits Recalled for Sterilization Calibration
Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2068-2026·2026-05-13
Mint Lesion Software Data Loss During Server Connection Interruption
Mint Medical is recalling Mint Lesion software versions 3.4.0 through 3.9.5 due to a risk of data loss or incorrect patient data linking when the workstation-to-server connection is interrupted during a read operation.
Product
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2081-2026·2026-05-13
BioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
BioFire Diagnostics, LLC is recalling the Spotfire Respiratory/Sore Throat Panel due to false negative test results and control failures that may not accurately detect infections.
Product
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
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-2050-2026·2026-05-13
Prodisc C SK Cervical Implant Size Labeling Mix-Up Recall
Centinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up: 6mm products were labeled as 5mm and 5mm products were labeled as 6mm, creating risk of implanting the wrong size.
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2026·2026-05-13
LUX-DX II Arrhythmia Detector Monitoring Function Data Collection Issue
Boston Scientific is recalling the LUX-DX II Model M302 and M312 arrhythmia detectors because some upgraded devices are not collecting PVC Burden data or monitoring for Bradyarrhythmia and Pause, with conflicting information shown in programming screens.
Product
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2096-2026·2026-05-13
Medline Convenience Kits Recalled for Sterilization Equipment Calibration
Medline is recalling certain Dental Pack and Surgical Pack convenience kits due to calibration issues with sterilization equipment that may affect sterility assurance. Approximately 3,508 units were distributed nationwide.
Product
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1981-2026·2026-05-13
[pending] Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor COR
Pending LLM rewrite. Source: FDA_DEVICE Z-1981-2026.
Product
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Category
Medical Device
Distribution
1 state
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-2089-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization calibration issue
Medline is recalling two models of Convenience Kits because calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2026·2026-05-13
Medline Surgical Device Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Product
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GY
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-2067-2026·2026-05-13
BioFire Joint Infection Panel diagnostic test kit contamination recall
BioFire Diagnostics is recalling its Joint Infection (JI) Panel diagnostic test kits due to contamination that may produce false positive results.
Product
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2127-2026·2026-05-13
Medline Arthroscopy Convenience Kits Recalled Due to Sterilization Equipment Calibration
Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Model Number: DYNJ22501G; 3) ARTHROSCOPY PACK, Model Number: DYNJ32715F; 4) CHS ARTHROSCOPY PACK, Model Number: DYNJ50834C; 5) ARTHROSCOPY TRAY-LF, Model Number: DYNJ51069
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2026·2026-05-13
Medline Convenience Kits Surgical Packaging Sterilization Calibration Issue
Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Product
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
Category
Medical Device
Distribution
Distributed nationwide
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-2104-2026·2026-05-13
Medline PPE Kit recalled for sterilization calibration issues
Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.
Product
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2026·2026-05-13
Medline Convenience Kits medical devices recalled due to sterilization calibration issues
Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.
Product
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2026·2026-05-13
Physio-Control Defibrillators May Lack Required Performance Inspection
Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.
Product
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2026·2026-05-13
Medline Basic Nerve Block Tray sterilization calibration issue
Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2026·2026-05-13
Medline Convenience Kits sterilization and packaging calibration issues recalled
Medline Industries is recalling multiple Convenience Kit models used in cardiac, vascular, and surgical procedures due to calibration issues with sterilization and packaging equipment that could impact sterility assurance. Approximately 39,341 units distributed worldwide may be affected.
Product
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model
Category
Medical Device
Distribution
Distributed nationwide

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126–150 of 390