Z-2296-2025Class II

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

Name: Z-2296-2025 Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Creator: Merit Medical Systems, Inc.
Published: 2025-06-05
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2025-06-05 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP on 2025-06-05. FDA classified it as Class II and gives the reason as "High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2296-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-05
Posted: 2025-08-12
Recalling firm: Merit Medical Systems, Inc.
Product: Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Product code: PPD Universal Drainage Tray
Reason for recall: High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to [email protected] If you have questions, contact the firm's customer service at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri
Quantity in commerce: 858
Distribution: US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
Product codes and lots: REF/UDI-DI/Lot(Expiration): K10-00353K/00884450179246/H3127803(1/4/2028), H3166061(2/24/2028), H3172299(3/14/2028); K10-01603C/00884450593639/H3163984(3/2/2028), H3176777(3/23/2028); K10-01694Q/00884450239308/H3116890(10/31/2027), H3152493(2/3/2028), H3177622(3/14/2028); K10-05159B/00884450153598/H3116922(12/23/2027), H3119571(1/4/2028), H3127907(1/11/2028), H3152490(2/10/2028), H3152491(2/10/2028), H3152492(2/10/2028); K10-05743/00884450456767/H3122012(1/6/2028), H3128429(1/13/2028), H3177446(3/16/2028); K10-05825AP/00884450808108/H3112585(11/27/2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2296-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12
Z-2294-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12
Z-2295-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12
Z-2296-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-12

Product code PPD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)