Medline Issues Correction for Convenience Kits With BD ChloraPrep

TL;DR: On September 2, 2026, the FDA classified Medline's correction of convenience kits containing BD ChloraPrep applicators as a Class II recall and added lot numbers, directing users to remove and discard the applicator and over-label kits.

Sept. 2 Update Changed Classification And Lot List

The FDA updated its communication on September 2, 2026 to add additional lot numbers to the affected product list, according to the FDA page titled Medline Issues Correction for Convenience Kits.

The same September 2 update informed the public that the issue has been classified as a Class II Recall, according to that FDA page.

The FDA page states that the agency has since determined that the device may cause temporary or reversible health problems, or — though unlikely — serious health problems.

That FDA page states that the recall involves correcting certain devices, and does not involve removing them from where they are used or sold.

The FDA page states that affected products have been updated and that recommendations for what to do with the devices have not changed.

An earlier timeline on the same FDA page records that the FDA issued an Early Alert communication on July 9, 2026 to notify the public of a potentially high-risk device issue.

The timeline records a second update on August 12, 2026 to add additional lot numbers to the affected product list.

The FDA page states that the agency continues to review information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

The page directs readers to continue to check the web page for updates.

Which Medline Kits Are Affected

The FDA page identifies the affected devices as Medline Convenience Kits and links to a full list of Affected Products.

The FDA page states that Medline has issued a letter to affected customers recommending certain convenience kits be corrected by removing BD ChloraPrep applicators affected by the BD ChloraPrep Recall.

A related FDA Enforcement Report for Event ID 99334 identifies one group of Medline Convenience Kits initiated by the firm on June 12, 2026 and posted on August 31, 2026 as Recall Number Z-3051-2026.

That enforcement record lists the products as IVS Blood Culture Kit Model Number DYNDH1920 and IVS Blood Culture Kit Model Number DYNDH1920A.

That record lists UDI-DI 10653160366317 for each DYNDH1920 unit and 00653160366310 for the case, with lot numbers 2023111390 and 2023121890.

That record lists UDI-DI 10653160385943 for each DYNDH1920A unit and 00653160385946 for the case, with lot number 2025022790.

That record lists quantity in commerce as 17,750 kits and distribution as U.S. nationwide distribution.

A second FDA Enforcement Report for Event ID 99561 identifies a Medline Convenience Kit containing BD ChloraPrep Clear 1 mL Applicators described as PAIN PRE OP KIT DYKS1476A.

That second record lists UDI-DI 10198459362835 with lots 25IBJ918, 25KBN677, 25LBU066 and 26BBD775.

That second record lists the firm initiation date as July 20, 2026, the posted date as August 31, 2026, and the recall number as Z-3067-2026.

The article titled Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals reports that 13 separate recall records posted in late August share recall event ID 99561 and were classified as Class II.

That article reports that the event covers a labor kit and vaginal delivery admission bag, an open heart pack, blood culture kits, IV start kits, an orthopedic aspiration kit, eye basin trays, patient admission kits, and several general pre-operative kits, alongside the cesarean prep tray.

That article reports a figure of 222,653 units in commerce for the recall event and states that the figure appears identically on individual records reviewed for the report, indicating it is the total for the event rather than a per-product count.

Why The ChloraPrep Applicator Triggered The Correction

Medline stated that Becton, Dickinson and Company is conducting a Drug Recall of specific lots of the BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators, according to the FDA correction page.

Medline stated the reason as potential breach of sterility in the packaging due to wrinkles in the paper lidding which may extend to the seal area, according to that FDA page.

Medline also stated that the affected product may exhibit an open or incomplete seal on the packaging of the applicator, according to that FDA page.

The FDA Enforcement Report for Recall Number Z-3051-2026 gives the manufacturer reason for recall as kits containing BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging due to wrinkles in the paper lidding which may extend to the seal area.

The FDA Enforcement Report for Recall Number Z-3067-2026 gives the manufacturer reason for recall as convenience kits containing BD ChloraPrep Clear 1 mL Applicators from specific lots recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging.

The FDA determined cause in both enforcement records is listed as Nonconforming Material/Component.

The FDA correction page links the action to related upstream recalls, including FDA Enforcement Reports for Event ID 99114 and Event ID 99377 and the FDA notice titled BD Issues Nationwide Recall for Specific Lots of ChloraPrep Clear Single Sterile 1 mL and FREPP Clear 1.5 mL Applicators Due to Microbial Contamination dated June 8, 2026.

The article titled Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals describes the defect as in one component inside the tray, the single-use swab used to disinfect skin immediately before a needle, incision, or catheter goes in.

Health Risk Described By FDA And Medline

The FDA correction page states that if the sterile barrier is compromised, patients and users may be exposed to microbial contamination.

That page lists potential health consequences as no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization.

That page states that in rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

That page states that patients who may have been exposed should be monitored according to clinical judgment for signs or symptoms of infection, and any suspected infection should be evaluated and treated promptly.

That page states that patients who may have been exposed without complications do not require follow up.

That page states that as of August 3, Medline has reported no serious injuries or deaths associated with this issue.

The FDA Enforcement Report for Recall Number Z-3067-2026 states that use of a potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

The article titled Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals reports that the FDA recall records reviewed for that report do not report any injuries.

That article states that risk is not evenly distributed for patients with a fresh abdominal incision after cesarean, patients with a central line or arterial line with a direct route into the bloodstream, and people receiving chemotherapy, taking immunosuppressants, living with poorly controlled diabetes, or recovering from a transplant.

That article lists signs of a surgical or procedure site infection as redness spreading outward from the site, warmth, swelling, new or worsening pain after the first few days, drainage that is cloudy or foul-smelling, and fever.

That article states that new parents recovering from a cesarean should treat a fever above 100.4 degrees Fahrenheit, or a wound that starts hurting more instead of less, as a reason to call the delivering provider rather than wait for the postpartum visit.

What Facilities Were Told To Do With Kits On Hand

The FDA correction page instructs users to remove affected BD ChloraPrep applicators and to apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.

The FDA page records that on June 12 and July 20, Medline sent all affected customers letters recommending actions for affected product.

The recommended actions listed on the FDA page are to immediately check stock for any affected product and quarantine.

The recommended actions also state that other components within the convenience kits may still be used.

The recommended actions also state to apply provided over-labels to any affected kits on hand stating that the affected component must be removed and discarded prior to use.

The recommended actions also state that if a customer is a distributor or has resold or transferred the product, the customer should notify those recipients of the recall communication.

The FDA Enforcement Report for Recall Number Z-3067-2026 states that the firm began notifying consignees on July 20, 2026 via first-class mail and email.

That record states that Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply, and that no kits are to be returned.

The FDA Enforcement Report for Recall Number Z-3051-2026 describes an urgent medical device recall notification letter dated June 12 and instructs customers to check stock for affected item and lot numbers listed within the recall portal and quarantine all affected product.

That record instructs customers to complete a response form, list the quantity of affected product in inventory, and submit the form even if no affected product is in inventory.

That record states that upon receipt of the submitted response form, the account will receive over-labels to place on affected inventory, with instructions for staff to remove and discard the affected component prior to using the kit.

That record states that the labels will be provided via FedEx overnight, if applicable.

That record states that a distributor or party that resold or transferred product to another company or individual is required by FDA regulations to notify them, include customer quantities on the response form, and will receive over-labels to provide to customers to affix to affected product.

The article titled Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals describes the corrective action as customers requesting stickers to over-label affected kits with an instruction telling staff to remove the affected applicator and replace it from separate supply, with no kits to be returned.

What This Means For Emergency And Home Medical Stockpiles

The FDA correction page describes convenience kits as containing various surgical instruments, dressings and/or other materials, and pharmaceutical components intended to be used during various surgical procedures.

The enforcement records describe product classifications including blood and urine collection kit and spinal epidural anesthesia kit, showing that convenience kits are pre-assembled clinical trays rather than consumer first-aid kits.

The article titled Cesarean and Delivery Prep Trays Are Among 13 Medline Kit Recalls Tied to Faulty Applicator Seals states that nobody has one of these trays in a medicine cabinet and describes them as standardized, pre-assembled trays that let a clinical team open one package instead of gathering separate items.

For preparedness planning, that distinction means the direct action applies to clinics, hospitals, and distributors holding Medline lots, not to checking a home cabinet for the same tray.

The same article states that the question is worth raising if a person had surgery, gave birth, or had a catheter placed at a U.S. hospital in recent months and then developed an unexplained infection at the site.

The same article states that anyone with a planned procedure can ask whether the hospital received the Medline notice and completed the correction.

The same article states that a record stays open until all affected product is corrected or removed, and notes that this recall remains open, meaning not all product has been corrected.

The FDA Enforcement Reports for both Recall Number Z-3051-2026 and Recall Number Z-3067-2026 list recall status as open, classified, with a note that the manufacturer has initiated the recall and not all products have been corrected or removed.

Contacts And Reporting Channels Listed For This Event

The FDA correction page states that customers in the U.S. with adverse reactions, quality problems, or questions about the issue should contact Medline at [email protected] or 866-359-1704.

The FDA Enforcement Report for Recall Number Z-3067-2026 lists an additional information contact as Haley Barclay at 800-633-5463 and identifies the recalling firm as Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093-2753.

The FDA Enforcement Report for Recall Number Z-3051-2026 lists the additional information contact as Haley Barclay at 866-359-1704 at the same Northfield address.

The FDA correction page states that health care professionals and consumers may report adverse reactions or quality problems experienced using the devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

The FDA correction page lists additional resources as the FDA Enforcement Report for Event ID 99334 and Event ID 99561, the CDRH Medical Device Recalls Database for the same event IDs, and related upstream recall reports.