FDA Medline Convenience Kits Recall Ledger: Class I And Class II Device Records

Status, June 30 source check: source-cleared for a BadPD FDA medical-device recall ledger. FDA’s AccessData recall records list one Class I Medline Convenience Kits recall record posted June 24, 2026 and two Class II Medline Convenience Kits recall records posted June 29, 2026. All three records list Medline Industries, LP of Northfield, Illinois as the recalling firm, list the recall status as open and classified, and list U.S. nationwide distribution.

This post is a source-labeled public-safety ledger, not clinical advice. Hospitals, clinics, distributors, and purchasers should follow FDA, Medline, supplier, and health-care facility instructions for affected product. BadPD is preserving the public records, the dates, the recall numbers, the product categories, the quantities in commerce, and the missing recovery facts that are not established by the public source set.

What FDA Posted

The first record, FDA AccessData record 220686, is titled “Class 1 Device Recall Medline Convenience Kits.” FDA lists the date initiated by firm as May 6, 2026 and the date posted as June 24, 2026. The recall number is Z-2453-2026 and the recall event ID is 99043. FDA lists the product classification as cardiovascular procedure kit, Product Code OEZ. The public record lists 6,775 units in commerce and U.S. nationwide distribution.

The second record, FDA AccessData record 221016, is titled “Class 2 Device Recall Medline Convenience Kits.” FDA lists the date initiated by firm as May 21, 2026 and the date posted as June 29, 2026. The recall number is Z-2542-2026 and the recall event ID is 99162. FDA lists the product classification as tray, surgical, Product Code LRP. The public record lists 15,662 kits in commerce and U.S. nationwide distribution.

The third record, FDA AccessData record 221017, is also titled “Class 2 Device Recall Medline Convenience Kits.” FDA lists the date initiated by firm as May 21, 2026 and the date posted as June 29, 2026. The recall number is Z-2543-2026 and the recall event ID is 99162. FDA lists the product classification as I.V. start kit, Product Code LRS. The public record lists 250 kits in commerce and U.S. nationwide distribution.

Why The Records Matter

The public-interest issue is not just that a large supplier posted recall notices. These records involve convenience kits used in medical settings. A kit recall can be harder for the public to interpret than a single retail product recall because the affected item may be a bundled kit, an included drug component, a model-number and lot-number combination, or inventory held by a facility or distributor rather than by an individual shopper.

FDA’s June 24 Class I record says the affected Medline Convenience Kits contain Arrow kits and sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA’s listed manufacturer reason says those included components were recalled due to quality issues identified during a recent FDA inspection of the supplier. BadPD is not expanding that into an injury claim. The record is about the public recall status, the component issue described by FDA, and the open correction/removal process.

FDA’s June 29 Class II records say the affected kits contain Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL ampules. FDA’s listed manufacturer reason says Huons Co., Ltd. issued a recall notice for those lidocaine ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. Again, BadPD is not claiming patient harm from these records. The verified fact is that FDA posted the records, classified them, and lists the recall actions as open.

The Recall Numbers

The clean way to read this cluster is by recall number and FDA record ID. The Class I record is Z-2453-2026, event 99043, record 220686. The two Class II records are Z-2542-2026 and Z-2543-2026, both tied to event 99162, records 221016 and 221017. Those identifiers matter because “Medline Convenience Kits” is a broad label. The FDA pages contain the model, UDI-DI, and lot information needed to identify affected inventory.

For the Class I cardiovascular procedure kit record, FDA’s product field lists open-heart, CABG, anesthesia, accessory, cardiac, and related kit model names. The public page also includes a long code-information field with model numbers, UDI-DI values, and lot numbers. For the Class II surgical-tray record, FDA’s product field includes suture tray, chest tube insertion tray, laceration tray, biopsy tray, radial arterial line kit, myelogram pack, and related models. For the Class II I.V. start kit record, FDA lists an arterial line kit model ART890B and an ultrasound guided IV securement set model IVS3350.

BadPD is not reproducing every lot line in the article body because the official FDA records are the controlling source and contain the full model and code lists. The practical instruction for accountable inventory work is to use the FDA record and Medline recall portal details, not a copied partial list from a news article. This post preserves the record IDs, recall numbers, event IDs, quantities, classifications, and source URLs so the full official fields remain one click away.

Action FDA Lists

All three FDA records describe urgent medical-device recall notification letters sent to customers. The June 24 Class I record says the letter was dated May 6, 2026. The two June 29 Class II records say the letter was dated May 21, 2026. The public action fields tell customers to check stock for affected item and lot numbers, quarantine affected product, complete a response form through the Medline recall portal, and report affected inventory even if none is on hand.

The FDA action fields also say affected accounts would receive over-labels with instructions for staff to remove and discard the affected component before using the kit, if applicable. The records say distributors or anyone who resold or transferred product are required by FDA regulations to notify their customers of the recall communication. FDA lists Medline’s recall department phone number as 866-359-1704 and the email address as recalls@medline.com in the public records.

That distributor-transfer language is the accountability hinge. A nationwide recall is not finished when the first buyer gets a letter. If a distributor, facility, or customer moved kits to another organization or individual, the notice must follow the product. The public records do not show how many downstream notices were sent, how many response forms were returned, how many kits were quarantined, how many affected components were removed, or when FDA will terminate the recalls.

Confirmed, Pending, And Not Established

Confirmed by FDA records

• FDA posted record 220686 on June 24, 2026 as a Class I Medline Convenience Kits recall, recall number Z-2453-2026, event 99043.
• FDA posted records 221016 and 221017 on June 29, 2026 as Class II Medline Convenience Kits recalls, recall numbers Z-2542-2026 and Z-2543-2026, event 99162.
• All three records list Medline Industries, LP of Northfield, Illinois as the recalling firm.
• All three records list recall status as open and classified.
• All three records list U.S. nationwide distribution.
• The public quantity fields list 6,775 units for Z-2453-2026, 15,662 kits for Z-2542-2026, and 250 kits for Z-2543-2026.

Reported by FDA’s manufacturer-reason fields

• The Class I record involves Medline kits containing Arrow kits and sets with Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP, with recalled components tied to quality issues identified during a recent FDA inspection of the supplier.
• The Class II records involve kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL ampules, with a Huons recall notice tied to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

Pending

• FDA termination status for all three recall records.
• Any public update showing completion of customer response forms, quarantines, component removals, over-labeling, or downstream distributor notification.
• Any public expansion, correction, or recall-number consolidation posted after the June 24 and June 29 records.

Not established by this source set

• Whether all affected kits have been located, quarantined, corrected, or removed.
• Whether any patient injury or adverse event is tied to these recall records.
• Whether every downstream purchaser received notice.
• Whether the inspection-identified quality issues are fully corrected at the supplier sites.

Practical Inventory Questions

The FDA records point to a practical workflow rather than a public panic. The people who can act on these records are procurement teams, supply-chain staff, clinical department managers, distributors, and compliance officers who can compare FDA model and lot fields against inventory. A household consumer is unlikely to have one of these clinical kits in a kitchen drawer. A hospital, clinic, distributor, emergency department, procedural suite, or warehouse may have them in ordinary stock.

The first question is whether affected item and lot numbers are physically present. The second question is whether product was quarantined before use. The third is whether the facility completed the response form even if inventory was zero. The fourth is whether the recall communication followed any product that was resold, transferred, or redistributed. FDA’s action language makes that downstream step explicit, so a clean internal memo is not enough if product left the original account.

The over-labeling language also matters. The FDA action fields do not simply say to discard every kit. They describe over-labels and instructions for staff to remove and discard affected components before use, when applicable. That is a controlled correction process. The public should not infer from this article that every kit was unusable in the same way or that every component inside every kit was defective. The accountable claim is narrower: FDA records say affected kit inventory required identification, quarantine, response reporting, and component-removal instructions.

Why Open Status Matters

FDA’s database notes explain that a recall record is updated as the action moves through classification and termination. Open status means the public record has not yet reached a final terminated state. That does not prove noncompliance, but it does mean the public record still has unfinished accountability value. A recall can be correctly initiated and still require weeks or months of inventory reconciliation, downstream notice, correction, and final FDA status updates.

For BadPD purposes, an open medical-device recall record is a watch item until FDA changes the status or publishes a final update. If a later FDA record changes cause wording, quantity, classification, product scope, or termination status, the article should be updated with the new date and exact record language. If the record stays open without public recovery detail, the missing-data list remains valid: response rate, corrected quantity, removed quantity, downstream notices, and termination date are still not established by the current source set.

BadPD Record Demand

BadPD will watch these records for FDA status changes, public termination notices, expanded product lists, or downstream-notification details. The missing data is basic but important: how many customers responded, how many affected units or kits remain uncorrected, how many distributors passed notice downstream, and when the FDA records move from open to terminated.

For now, the source-cleared public record is narrow and strong. FDA has three official records. One is Class I and two are Class II. The recalling firm is Medline Industries, LP. The dates posted are June 24 and June 29, 2026. The public quantities add up to 22,687 listed units or kits across the three records. Distribution is listed nationwide. The action fields tell customers to quarantine affected stock, complete the Medline response process, and notify downstream customers if product was transferred.

BadPD’s position is simple: medical-device recall records should not disappear into database pages that only procurement staff can parse. When the product is a kit used in clinical settings and the action depends on model numbers, lot numbers, over-labels, and component removal, the public needs a clear ledger of what is confirmed, what is still open, and what proof is missing.

Source Ledger

• FDA AccessData recall record 220686, Medline Convenience Kits, posted June 24, 2026, Z-2453-2026
• FDA AccessData recall record 221016, Medline Convenience Kits, posted June 29, 2026, Z-2542-2026
• FDA AccessData recall record 221017, Medline Convenience Kits, posted June 29, 2026, Z-2543-2026
• FDA Enforcement Reports landing page for recall records

Featured image is symbolic editorial artwork created for BadPD. It is not FDA product photography and is not a depiction of Medline inventory, supplier facilities, clinical use, or any patient.