Class II recall Z-0171-2027: Medline Industries, LP

Class II recall Z-0171-2027: Medline Industries, LP (Illinois): Medline Industries, LP. Dated 15 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of · 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.

FieldValue
RecordDevice recall
Recall numberZ-0171-2027
Recalling firmMedline Industries, LP
ClassificationClass II
StatusOngoing
Voluntary / mandatedVoluntary: Firm initiated
SpecialtyOther
ProductMedline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-
ReasonMedical 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.
Quantity8374 kits
DistributionUS Nationwide distribution.
Recall initiated2026-09-02
Reported2026-10-21
Firm locationNorthfield, IL, United States
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-21
  • Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT

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Peer benchmark and outreach value: Class II recall Z-0171-2027: Medline Industries, LP and 57 Illinois peers

  • 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)

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62 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Class II recall: usually triggers CAPA and quality-system remediation work.
  • Recall is still ongoing.
  • Posted 15 days ago.

What is the FDAPulse record for Class II recall Z-0171-2027: Medline Industries, LP in Illinois?

Class II device recall Z-0171-2027 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-0171-2027: Medline Industries, LP compare to other Illinois FDAPulse records?

It is 15 days old, still within a typical 45-day follow-up window.

Class II recall Z-0171-2027 vs. top 2 peers

OrganizationLocationRecord date
Class II recall Z-0171-2027IL2026-10-21
Class II recall Z-0281-2027IL2026-10-28
Class II recall Z-0275-2027IL2026-10-28

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