Medline
371 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medline and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DeviceClass IIStop using Medline Nail Kit DYKM1528
Medline has recalled specific lots of its Nail Kit (Model DYKM1528) because the sterile saline wound wash included in the kit may not meet required sterility standards. The saline solution could potentially be contaminated. No injuries have been reported so far.
- 2026-03-04FDA-DeviceClass IIStop using Medline Convenience Kits
Medline recalled five models of Convenience Kits because the sterile saline wound wash component may not meet required sterility safety standards. The affected kits were distributed for medical use. No injuries have been reported.
- 2026-03-04FDA-DeviceClass IIStop using Medline Convenience Nail Kit
Medline is recalling specific lots of its Convenience Nail Kit because the sterile saline wound wash component may not meet required sterility standards. The affected product was distributed nationwide and to several Caribbean locations. No injuries have been reported.
- 2026-03-04FDA-DeviceClass IIStop using Medline Sterile Saline Wound Wash
Medline Industries recalled its 7.1 FL OZ Sterile Saline Wound Wash because the manufacturer may not have properly sterilized the product to meet safety standards. This affects all lots of model MDSALINE7 distributed nationwide and in the Caribbean. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck your Medline surgical packs
Medline Industries identified calibration problems with equipment used to sterilize and package certain surgical packs. While the packs went through the standard sterilization process, the equipment issues may have affected their sterility. This recall affects specific lot numbers of Universal UltraGard and Shoulder Drape Pouch surgical packs.
- 2026-02-25FDA-DeviceClass IIStop using recalled Medline surgical gowns
Medline has recalled multiple models of surgical gowns due to calibration problems with sterilization equipment. While the gowns went through sterilization cycles, equipment calibration issues may have affected their sterility. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck Medline surgical drapes for sterilization defects
Medline Industries recalled multiple surgical drape products due to calibration problems with sterilization equipment. While the drapes went through sterilization and packaging, equipment calibration issues may have compromised their sterility. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck Medline arthroscopy kits for sterilization defects
Medline discovered that equipment used to sterilize and package certain arthroscopy surgical kits had calibration problems. While the kits went through sterilization, the equipment issues may have affected whether the products met required sterility standards. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck Medline surgical kits for sterilization issue
Medline has recalled multiple surgical convenience kits used in orthopedic and neurosurgery procedures due to calibration issues with sterilization equipment. While the kits went through sterilization cycles, equipment calibration problems may have affected their sterility assurance. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck Medline surgical kits for sterilization recall
Medline Industries identified calibration problems with equipment used to sterilize and package certain surgical and eye surgery convenience kits. Although the kits went through sterilization cycles, the calibration issues may have affected how reliably the sterilization worked. No infections or injuries have been reported.
- 2026-02-25FDA-DeviceClass IICheck Medline surgical kit lot numbers
Medline Industries recalled multiple surgical convenience kits used in hospitals and surgical centers because equipment used to sterilize and package them had calibration problems. Although the kits went through sterilization cycles, the calibration issues may have affected their sterility. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using affected Medline surgical kits
Medline Industries recalled multiple surgical convenience kits used in gynecological and other procedures because of calibration problems in the sterilization equipment. Although the kits went through standard sterilization cycles, the equipment issues may have compromised their sterility.
- 2026-02-25FDA-DeviceClass IIStop using recalled Medline C-section kits
Medline Industries recalled multiple models of C-section surgical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization cycles, equipment calibration issues may have compromised their sterility. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using affected Medline urology kits
Medline Industries identified calibration problems with sterilization equipment used to process certain urology surgical kits. While the products went through sterilization cycles, the equipment issues may have affected whether the devices are truly sterile. This affects five models of urology kits distributed nationwide.
- 2026-02-25FDA-DeviceClass IIStop using affected Medline surgical kits
Medline has recalled multiple surgical convenience kits used in gynecological, urological, and other surgical procedures due to calibration problems with sterilization equipment. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility assurance level, potentially compromising the sterility of the devices.
- 2026-02-25FDA-DeviceClass IICheck Medline delivery kits for sterilization concerns
Medline Industries identified calibration problems with equipment used to sterilize and package obstetric and gynecology convenience kits. While the kits went through sterilization cycles, the equipment calibration issues may have affected whether the products met required sterility standards. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using Medline neuro surgical kits
Medline recalled multiple neurological surgical kits due to calibration problems in the sterilization equipment used to process them. Although the kits went through the standard sterilization process, calibration issues may have reduced the sterility assurance level of the products.
- 2026-02-25FDA-DeviceClass IICheck Medline Convenience Kit lot numbers
Medline Industries has recalled certain Chest/Breast-LF Convenience Kits (Model DYNJ83950) because equipment used to sterilize and package them had calibration problems. While the kits went through sterilization cycles, the calibration issues may have affected whether they meet required sterility standards. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using affected Medline medical trays
Medline identified calibration problems with sterilization equipment used to process certain LVAD driveline and central line dressing change trays. These issues may have affected the sterility of the devices, even though they went through standard sterilization cycles. The recall affects specific lot numbers manufactured between 2020 and 2025.
- 2026-02-25FDA-DeviceClass IIStop using Medline Admit Kit DYKA1343A
Medline has recalled certain batches of its Admit Kit (model DYKA1343A) due to calibration problems with the sterilization equipment used to package them. While the kits went through sterilization, the equipment issues may have affected how well they stayed sterile. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using Medline Convenience Kits
Medline identified calibration problems with equipment used to sterilize and package two models of convenience kits: the Drape Pack (Model DYNJ35363A) and Sick Kids-General Custom Split (Model SPTPCD10005). While the products went through sterilization cycles, the calibration issues may have affected whether the products remained properly sterile.
- 2026-02-25FDA-DeviceClass IICheck your Medline PPE kit lot number
Medline Industries identified calibration problems with equipment used to sterilize and package certain PPE Convenience Kits. Although the products went through sterilization, the equipment issues may have affected how well the sterility protection worked. Multiple lot numbers from 2021 through 2025 are involved.
- 2026-02-25FDA-DeviceClass IIStop using Medline triple lumen insertion kit
Medline identified calibration problems with equipment used to sterilize and package their triple lumen insertion kits (Model DYNDM1031A). While the kits went through sterilization, the calibration issues may have affected whether they are truly sterile. This affects 15 units with lot number 23EBM150.
- 2026-02-25FDA-DeviceClass IIStop using Medline DRAPE PACK-CHOICE kits
Medline identified calibration problems in the equipment used to sterilize and package DRAPE PACK-CHOICE kits (Model DYNJ63118A). While the products went through sterilization cycles, the equipment calibration issues may have affected whether the products are properly sterile.
- 2026-02-25FDA-DeviceClass IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- 2026-02-25FDA-DeviceClass IIStop using Medline burn care kits
Medline has recalled three models of burn care convenience kits because equipment used to sterilize and package them had calibration problems. While the products went through sterilization cycles, the calibration issues may have affected whether the kits are properly sterile. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using Medline Convenience Kits DYNJ50806L
Medline identified calibration problems with the equipment used to sterilize and package certain Convenience Kits (Model DYNJ50806L, Lot 23FBK937). While the products went through sterilization, the equipment calibration issues may have affected whether the devices are properly sterile. This could potentially compromise the safety of the medical devices.
- 2026-02-25FDA-DeviceClass IICheck Medline surgical kits for recall
Medline has recalled certain LVAD driveline trays and central venous insertion kits due to calibration problems with sterilization equipment. These devices may not meet required sterility standards, even though they went through sterilization cycles. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIStop using Medline convenience kits
Medline has recalled six types of surgical and medical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization and packaging processes, the calibration issues may have compromised the sterility of the products. No injuries have been reported.
- 2026-02-25FDA-DeviceClass IIMedline 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 CAPSULOTOMY, Model Number: DYKM1756A; 6) TOTE FOX OSC HAND REPAIR, Model Number: DYKM1783A; 7) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 8) TOTE SB NGUYEN LIPOSUCTION, Model Number: DYKM1927A; 9) TOTE YA
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
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