Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0169-2027%22

Class II recall Z-0169-2027: Medline Industries, LP

Q: How to monitor Class II recall Z-0169-2027: Medline Industries, LP and peer other records

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Class II recall Z-0169-2027: Medline Industries, LP (Illinois): Medline Industries, LP. Dated 14 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of 2026-11-03 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.

Field	Value
Record	Device recall
Recall number	Z-0169-2027
Recalling firm	Medline Industries, LP
Classification	Class II
Status	Ongoing
Voluntary / mandated	Voluntary: Firm initiated
Specialty	Other
Product	1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product N
Reason	Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Quantity	1834 kits
Distribution	US Nationwide distribution.
Recall initiated	2026-09-02
Reported	2026-10-21
Firm location	Northfield, IL, United States
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL

Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-10-21
Data refreshed: 2026-11-03
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-0169-2027: Medline Industries, LP and 57 Illinois peers

Your role Typical deal size (USD) Assumed reply-to-deal rate (%)

Illinois FDAPulse records like this one: 57
Timing: Medium: dated in the last 30 days
Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

Class II recall: usually triggers CAPA and quality-system remediation work.
Recall is still ongoing.
Posted 14 days ago.

What is the FDAPulse record for Class II recall Z-0169-2027: Medline Industries, LP in Illinois?

Class II device recall Z-0169-2027 by Medline Industries, LP: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional

How does Class II recall Z-0169-2027: Medline Industries, LP compare to other Illinois FDAPulse records?

It is fresh: dated 14 days ago, inside the window where early outreach matters most.

Class II recall Z-0169-2027 vs. top 2 peers

Organization	Location	Record date
Class II recall Z-0169-2027	IL	2026-10-21
Class II recall Z-0281-2027	IL	2026-10-28
Class II recall Z-0275-2027	IL	2026-10-28

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