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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82066

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 31, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medline Industries Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case with two boxes. One box includes 50 eaches of liners in a poly bag and the second box includes 50 eaches of lids in a poly bag. For OR530H, the customer receives the number of liners and lids purchased in one case without the individual boxes. The "H" denotes a single quantity when being ordered.

Z-0174-2020
Recall number
Z-0174-2020
Initiated
January 31, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries Inc
Quantity
750 eaches

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the Semi-Rigid canister lid to fragment during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the Semi-Rigid canister lid to fragment during use.

Code information

Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1

Distribution pattern

Nationwide distribution to AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MT, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, VA, VT, WI.