FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Rigid Suction Canister 3000 CC and 2000 CC.
- Recall number
- Z-0352-2017
- Recalling firm
- Medline Industries Inc
- Product
- Rigid Suction Canister 3000 CC and 2000 CC.
- Status
- Terminated
- Initiated
- 2016-08-10
- Posted
- not on file
- Terminated
- 2019-06-03
- Reason
- Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
- Root cause
- Process control
- Action
- Medline Industries, Inc. sent an Urgent Recall Immediate Action Required letter dated August, 23, 2016, and destruction form via first class mail to affected customers on August 17, 2016 and August 23, 2016. The firm recommended the following actions: REQUIRED ACTION: 1. Immediately check your stock for item number OR220 and OR230 with lot numbers beginning with 9961601xxxx through 9961604xxxx (listed on the original case packaging). Destroy all affected products. If the rigid canisters are NOT in the original case packaging, we are instructing you to destroy them and we will send replacements. 2.Please return the completed enclosed destruction form listing the quantity of product(s) destroyed. Even if you do not have any of this product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacements. 3.If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704.
- Quantity
- 7,680 units
- Distribution
- US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.
- Lot, serial or model codes
- RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28