Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF, Pack Number DYNJ900709D; f) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723C; g) GENERAL LAPAROSCOPY-LF, Pack Number DYNJ900723D; h) CYSTO, Pack Number DYNJ908098A; i) MINOR LAPAROTOMY, Pack Number DYNJ908428; j) MERCY TIFFIN BASIC LAP-LF, Pack Number DYNJ909730
Why it was recalled
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
a) CDS981509C: UDI/DI case 40195327071173, UDI/DI each 10195327071172, Lot Numbers: 24ABS277; b) CDS981512J: UDI/DI case 4019532759782610195327597825, Lot Numbers: 24BBP412; c) CDS981515D: UDI/DI case 4019532707196810195327071967, Lot Numbers: 23KDC374, 24CDB523, 24EDA579; d) DYNJ900709C: UDI/DI case 4019348995099210193489950991, Lot Numbers: 23LBU953; e) DYNJ900709D: UDI/DI case 4019532763531310195327635312, Lot Numbers: 24CBQ684; f) DYNJ900723C: UDI/DI case 4019348995162310193489951622, Lot Numbers: 24ABL637; g) DYNJ900723D: UDI/DI case 4019532763534410195327635343, Lot Numbers: 24CBG030, 24CBO759, 24EBJ696; h) DYNJ908098A: UDI/DI case 4019532750725210195327507251, Lot Numbers: 24ABY035; i) DYNJ908428: UDI/DI case 4019532707116610195327071165, Lot Numbers: 24ABK094; j) DYNJ909730: UDI/DI case 4019532746453110195327464530, Lot Numbers: 24CBS071, 24EBI597
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-3110-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Northfield, IL
- Recall initiated
- 2024-06-27
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-3110-2024 · Source: openFDA enforcement.