Z-0174-2020Class II

Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case...

Name: Z-0174-2020 Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the product comes in a case...
Creator: Medline Industries Inc
Published: 2019-01-31
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-01-31 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of 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... on 2019-01-31. FDA classified it as Class II and gives the reason as "Potential for the Semi-Rigid canister lid to fragment during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0174-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-31
Posted: 2019-10-22
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Potential for the Semi-Rigid canister lid to fragment during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On about 01/31/2018 Medline notified customers via "URGENT RECALL" letter. Instructions included to immediately check inventory for and quarantine all affected product, complete and return the response form, and notify customers if the product has been further distributed and instruct them to return products to Medline Industries, Inc. Once the response form is received, return labels will be provided to return all affected product. For questions call 866-359-1704.
Quantity in commerce: 750 eaches
Distribution: 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.
Product codes and lots: Model Numbers OR530, OR530H; Lot Numbers 20180914-1, 20180913-1, 20180916-1, 20180929-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0174-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-30	2019-10-22

Product code KDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)