Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, ...

FDA Device Recall #Z-0156-2025 — Class II — September 4, 2024

Recall Summary

Recall Number Z-0156-2025
Classification Class II — Moderate risk
Date Initiated September 4, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 2631 units

Product Description

Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A

Reason for Recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Lot / Code Information

a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers: 23LBI662; b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers: 23LBM830; c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers: 23LBP126; d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers: 23LBP442; e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers: 24ABB296; f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers: 23LBK382; g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers: 24ABF463; h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers: 23LBL339; i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers: 23LBR317; j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers: 23LBL628; k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers: 24ABA421; l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers: 23KBB860; m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers: 23LBL699; n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers: 23EBD843A; o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers: 24ABN915; p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers: 23LBQ949; q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers: 23LBR843; r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers: 23LBP174; s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers: 23LBS865; t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers: 24BBA256; u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABN040; v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABD377; w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers: 24ABV352

Other Recalls from MEDLINE INDUSTRIES, LP - Northfield

Recall # Classification Product Date
Z-2567-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2566-2025 Class I Medline medical convenience kits labeled as: ... Jul 25, 2025
Z-2479-2025 Class II Medline Kits containing BD SureStep Foley Tray ... Jul 23, 2025
Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
Z-2452-2025 Class II The Medline General Surgery Tray is customized ... Jul 8, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from MEDLINE INDUSTRIES, LP... Recalls by Firm Recall Reasons Device Safety Stats