Data Foundry

Medical device recalls 2019

Semi-Rigid Suction Canister — Class II medical device recall Z-0174-2020

Ongoing recall by Medline Industries Inc, reported 2019-10-30, distributed nationwide. Potential for the Semi-Rigid canister lid to fragment during use.

Recall numberZ-0174-2020
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries Inc, Northfield, IL, United States
Recall initiated2019-01-31
Classified2019-10-22
Reported by FDA2019-10-30
DistributedNationwide (US)
Quantity750 eaches
Lot numbers20180913-1, 20180914-1, 20180916-1, 20180929-1
Model numbersOR530, OR530H

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0174-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.