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 medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;
Why it was recalled
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers: 23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116; b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers: 22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933; c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers: 22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072; d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers: 22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077; e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers: 22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543; f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers: 22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250; g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers: 22JDA825, 22LDB688, 23HDC128, 23KDA676; h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers: 22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988; i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers: 23JBH731; j) REF DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers: 22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064; k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers: 22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177; l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers: 23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256; m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers: 22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012; n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers: 23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450; o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers: 22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490; p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers: 23IMI101, 23KMB382; q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers: 23GBD871, 23IBT374, 23KBD099;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Recall record
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product type
- Devices
- Recall number
- Z-2704-2024
- 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
- 2024-03-22
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-2704-2024 · Source: openFDA enforcement.