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

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826–850 of 13381

HighFDA (Devices)·Z-1394-2026·2026-02-25
Medline Surgical Device Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries, LP is recalling 9,051 surgical device kits due to sterilization equipment calibration issues that could compromise sterility assurance levels. The recalled kits may not be adequately sterile despite undergoing validated sterilization processes.
Product
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1396-2026·2026-02-25
Medline Endoscopy Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling over 23,000 endoscopy procedure kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
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
HighFDA (Devices)·Z-1377-2026·2026-02-25
Olympus Thunderbeat Surgical Device Removal Due to Adverse Events
Olympus Corporation is removing Thunderbeat surgical instruments worldwide due to continued reports of adverse events. The 5 mm, 45 cm pistol grip devices affected include all manufacturing lots.
Product
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2026·2026-02-25
Medline Surgical and Biopsy Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 2,740 surgical and biopsy convenience kits due to calibration issues with sterilization equipment that may have compromised product sterility. No injuries have been reported.
Product
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2026·2026-02-25
Baxter Spectrum IQ Infusion Pump Recalled Over Incomplete Occlusion Alarm Testing
Baxter is recalling 5 Spectrum IQ infusion pumps distributed in Ohio due to incomplete testing, specifically missing occlusion alarm testing, which could affect medication delivery safety.
Product
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1415-2026·2026-02-25
Medline Surgical Convenience Kits Recalled for Sterilization Equipment Calibration Issues
Medline is recalling 12,418 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. No illnesses have been reported.
Product
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2026·2026-02-25
Medline Burn Care Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling 291 units of three burn care convenience kit models due to calibration issues with sterilization equipment that may impact product sterility. No illnesses or injuries have been reported.
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
HighFDA (Devices)·Z-1375-2026·2026-02-25
Olympus Thunderbeat Surgical Device Recalled Due to Adverse Event Reports
Olympus has initiated a removal of Thunderbeat 5 mm surgical devices following continued reports of adverse events. The affected devices were distributed worldwide, including throughout the United States.
Product
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1413-2026·2026-02-25
Medline Neurosurgery Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling 7,494 neurosurgery convenience kits due to sterilization equipment calibration problems that could impact sterility assurance. No illnesses or injuries have been reported.
Product
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1370-2026·2026-02-25
Medica Capillary Tubes recalled due to potassium measurement bias
Medica Capillary Tubes used in blood gas testing show a systematic positive bias of up to 20% in potassium measurements, resulting in false elevation results that could affect clinical decisions.
Product
Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1424-2026·2026-02-25
Medline Surgical Gowns Recalled for Sterilization Equipment Calibration Issues
Medline is recalling surgical gowns due to calibration issues in sterilization and packaging equipment that could impact sterility assurance. No illnesses have been reported.
Product
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP2002; 4) GOWN,SIRUS,NONRNF,SETINSLV,XL,20/CS, Model Number: DYNJP2002S; 5) GOW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2026·2026-02-25
Medline Surgical Kits Recalled for Potential Sterilization Compromise
Medline is recalling labor and delivery surgical kits due to calibration issues in sterilization equipment that could compromise product sterility. The recall affects 27,320 units distributed nationwide and worldwide.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2026·2026-02-25
Stryker MOLLI 2 Surgical Markers Recalled for Dislodgement Risk
Stryker Corporation recalls MOLLI 2 surgical markers due to dislodgement risk when magnetized surgical tools are used during procedures. The company is updating product labeling to address the issue.
Product
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 008500241951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2026·2026-02-25
Medline Convenience Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries is recalling 1,496 Convenience Kits due to calibration issues with sterilization and packaging equipment. The calibration defects could compromise the sterility assurance of these surgical instrument kits.
Product
Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2) TOTE SEN OSC HAND REPAIR, Model Number: DYKM1776; 3) TOTE MOMENI SB CAPSULOTOMY REC, Model Number: DYKM1765A; 4) TOTE YAO OSC HAND REPAIR, Model Number: DYKM1796A; 5) TOTE SB NGUYEN CA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2026·2026-02-25
Medline Surgical Packs Recalled for Sterilization Equipment Calibration Issues
Medline Industries recalls over 193,000 surgical packs due to sterilization equipment calibration issues that could compromise sterility assurance. No injuries have been reported.
Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1391-2026·2026-02-25
Medline PICC and Central Line Procedure Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries is recalling 5,346 sterile surgical procedure kits due to calibration issues in sterilization equipment that may compromise sterility assurance. The kits were distributed nationwide.
Product
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1364-2026·2026-02-25
Medical device wound dressing recalled for potential sterile packaging barrier failures
Integra LifeSciences is recalling Medihoney Calcium Alginate wound dressings due to potential packaging failures that could breach the sterile barrier and increase infection risk.
Product
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2026·2026-02-25
Medline surgical and ophthalmology kits recalled for sterilization equipment calibration issues
Medline is recalling 4,853 surgical and ophthalmology convenience kits due to calibration issues with sterilization equipment that could compromise sterility assurance. No illnesses have been reported.
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-1422-2026·2026-02-25
Medline Arthroscopy Surgical Kits Recalled Over Sterilization Calibration Issue
Medline Industries recalled five arthroscopy surgical kit models due to calibration issues with sterilization and packaging equipment that could compromise sterility assurance. The recall affects 175 units distributed nationwide.
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-1428-2026·2026-02-25
Da Vinci 5 Surgical System Software Error Causes Monitor Display Loss
Intuitive Surgical is recalling 12 Da Vinci 5 surgical systems due to a software error that can cause loss of user interface content on external monitors, potentially impairing surgeon visualization during minimally invasive procedures.
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1390-2026·2026-02-25
Medline Surgical Device Kits Recalled for Sterilization Calibration Issues
Medline is recalling approximately 39,315 surgical device kits due to calibration issues in sterilization equipment that could compromise device sterility. The affected kits are used in cardiac, vascular, and general surgical procedures.
Product
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1417-2026·2026-02-25
Medline C-Section Surgical Kits Recalled for Sterilization Equipment Calibration Issues
Medline Industries is recalling 4,525 C-section surgical kits due to calibration problems with sterilization equipment that could affect sterility assurance. No injuries have been reported.
Product
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2026·2026-02-25
Medline Urology Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling five types of urology convenience kits due to calibration issues with sterilization equipment that may have compromised the sterility assurance of the devices. Approximately 59 units distributed nationwide are affected.
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
HighFDA (Devices)·Z-1421-2026·2026-02-25
Medline Surgical Kits Recalled Due to Sterilization Equipment Calibration Issues
Medline is recalling surgical convenience kits used in orthopedic procedures due to sterilization equipment calibration issues that could compromise sterility assurance. The recall affects approximately 117,907 units distributed nationwide.
Product
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1380-2026·2026-02-25
Olympus Thunderbeat Surgical Instrument Recalled for Adverse Events
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat surgical instrument due to continued reports of adverse events. Approximately 52 units were distributed worldwide.
Product
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Category
Medical Device
Distribution
Distributed nationwide

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826–850 of 13381