The FDA classified a recall on August 31 covering the Medline Ultrasound Breast Pack, a pre-assembled sterile convenience kit named for use in ultrasound-guided breast procedures. One lot totaling 300 kits, distributed nationwide, is affected according to the FDA recall record, which lists the product under the plastic surgery and accessories kit category.
The number is small. The patient population is not incidental. Ultrasound-guided breast procedures often sit between an abnormal imaging finding and a diagnosis, which means the people in these rooms can include patients awaiting a cancer diagnosis and patients already in cancer treatment.
The defect involves the skin preparation applicators packed inside. Wrinkles in the paper lidding of the pouch may extend into the seal area. If the sterile barrier is compromised, the FDA record states that patients and users may be exposed to microbial contamination.
A Single Lot of 300 Breast Ultrasound Packs
The affected product is model number DYNJ63375C, lot 23LMC035. Medline initiated the action on June 12, and the FDA classified it as Class II on August 31. The record remains open.
Medline sent an urgent medical device recall notification to customers instructing them to check stock, quarantine affected product, and submit a response form. Facilities then received over-the-labeling with instructions to remove and discard the affected applicator before using the kit. Distributors that resold the product were required to notify their own customers.
The kits contain both BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators. Both are chlorhexidine-based skin preparation swabs used to disinfect an area before a needle enters it.
The Wrinkled Lidding Defect Behind Sixteen Records
The breast pack is one of 16 records sharing a single recall event. The event listing shows how far the same applicator defect reached into unrelated corners of hospital care.
Also covered are blood draw and phlebotomy kits, whole blood and double red cell collection kits, arterial line insertion kits, a cricothyrotomy kit, an anesthesia labor and delivery arterial line set, a colorectal pack, blood culture trays, and a tray containing a pediatric emergency kit. A defect in one swab pouch propagated into pediatric emergency care, blood donation collection, and airway rescue equipment because the same component sits inside all of them.
The FDA has published an update on the Medline convenience kit alert describing the lidding defect, and a separate early alert covering fungal contamination in two specific BD applicator lots. That second alert matters for facilities holding this inventory: on August 11, Medline told customers that for the products named in it, the required action had changed from over-labeling to destroying the entire kit, because of contamination that can allow growth of the mold Aspergillus penicillioides. Medline reported no serious injuries or deaths associated with that issue as of August 17.
Cancer Patients and Others with Weakened Immune Systems
The FDA record is unusually specific about who carries the most exposure. Potential consequences range from no injury to localized infection, and less commonly to infection requiring antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, the record states that severe infection "could become life-threatening."
That language is not boilerplate in this context. A patient undergoing an ultrasound-guided breast procedure may be neutropenic from chemotherapy, may be taking immunosuppressants for an autoimmune condition, or may have a port or central line already in place. For those patients, a skin flora exposure that a healthy adult would clear without noticing can become a bloodstream infection.
Warning signs after a breast procedure include redness spreading from the puncture site, warmth, firm swelling, pain that worsens after the first two days rather than improving, drainage, or fever. Patients on active cancer treatment should follow the fever threshold their oncology team gave them, which is often lower than general guidance, and call the on-call line rather than wait.
Questions Worth Raising Before a Breast Procedure
No patient can check a lot number on a kit, and none should be expected to. Nobody has these packs at home.
What is reasonable is a short conversation. Anyone scheduled for an ultrasound-guided breast procedure can ask whether the facility received the Medline notice and completed the correction. Patients treated with one of these kits can ask their care team whether their procedure fell within the affected lot window, though most facilities will not have tracked kits to individual patients.
What no reader should do is delay a diagnostic breast procedure over this. A postponed biopsy carries a far more concrete risk than a Class II packaging defect on 300 kits, and the FDA has not restricted use of corrected inventory.
Several things remain unresolved. The recall is open, meaning not all affected product has been corrected or removed. The FDA records reviewed for this report do not report injuries or infections tied to the defect. No public data exists on how many of the 300 kits were used before the notification reached facilities.
The individual recall records will be updated as the status changes, and problems can be reported to the FDA through the MedWatch program. Medline directs customers to its recall portal and its recall department for lot-specific questions.
Key Questions Answered
What was recalled? One lot of 300 Medline Ultrasound Breast Packs, model DYNJ63375C, lot 23LMC035, plus 15 other Medline kit records in the same recall event.
What is wrong with them? The BD ChloraPrep and FREPP skin preparation applicators inside may have wrinkles in the paper lidding extending into the seal area, which can compromise the sterile barrier.
Should I postpone a breast procedure? No. Delaying a diagnostic procedure carries greater risk. The FDA has not restricted use, and facilities were told to remove and replace the affected applicator.
Who is most vulnerable? Critically ill and immunocompromised patients, including people on chemotherapy or immunosuppressants and those with indwelling lines.
What symptoms should I watch for? Spreading redness, warmth, firm swelling, pain worsening after the first two days, drainage, or fever after the procedure.
Is this the same as the fungal contamination alert? No. That action involves specific applicator lots contaminated with a mold, and for those lots the instruction changed to destroying the whole kit. This record involves a packaging seal defect.
Have any infections been reported? The FDA recall records reviewed for this report do not report injuries. The action is precautionary, based on a packaging inspection finding.
