CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Medline convenience kits containing semi-rigid suction recalled
Medline Industries LP - Northfield is recalling Medline convenience kits containing semi-rigid suction liners labeled as follows: a), distributed nationwide in the US. The recall was initiated on 27 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3121-2024
- FDA event ID
- 95128
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2024
- FDA classified
- 11 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 27 Jun 2024 | Recall initiated by company | |
| 11 Sep 2024 | Classified by FDA | +76 days |
| 18 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D; c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F; d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C; e) LAMINECTOMY, Pack Number DYNJ908091B; f) PODIATRY, Pack Number DYNJ908092C; g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B; h) CRANI, Pack Number DYNJ908097A; i) HIP PINNING, Pack Number DYNJ908102B; j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B; k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B; m) HAND-LF, Pack Number DYNJ908425; n) TOTAL JOINT, Pack Number DYNJ908660A; o) MERCY TIFFIN HAND, Pack Number DYNJ909734; p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738; q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740; r) ACL-WHSC, Pack Number DYNJ910074A; s) EXTREMITY-WHSC, Pack Number DYNJ910077; t) EXTREMITY-WHSC, Pack Number DYNJ910077A; u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A; v) MICRODISC, Pack Number DYNJ910370; w) MTHZ TOTAL HIP, Pack Number DYNJC9311L
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Questions about this recall
Why was it 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.
Which lots are affected?
a) CDS981510L: UDI/DI case 40195327195435, UDI/DI each 10195327195434, Lot Numbers: 23LDB386, 23LDB793; b) DYNJ900720D: UDI/DI case 40193489951593, UDI/DI each 10193489951592, Lot Numbers:23LBT897; c) DYNJ900720F: UDI/DI case 40195327635337, UDI/DI each 10195327635336, Lot Numbers: 24CBC838, 24EBH235; d) DYNJ908090C: UDI/DI case 40195327507245, UDI/DI each 10195327507244, Lot Numbers: 24CBH612, 24FBA023; e) DYNJ908091B: UDI/DI case 40195327507023, UDI/DI each 10195327507022, Lot Numbers: 24CBK626; f) DYNJ908092C: UDI/DI case 40195327507030, UDI/DI each 10195327507039, Lot Numbers: 23LBU932, 24ABT063, 24CBP714; g) DYNJ908095B: UDI/ DI case 40195327507184, UDI/DI each 10195327507183, Lot Numbers: 24ABO437, 24ABW989, 24EBH236; h) DYNJ908097A: UDI/DI case 40195327507078, UDI/DI each 10195327507077, Lot Numbers:23LBV779, 24CBU878; i) DYNJ908102B: UDI/DI case 40195327507191, UDI/DI each 10195327507190, Lot Numbers: 24BBI407; j) DYNJ908103B: UDI/DI case 40195327507108, UDI/DI each 10195327507107, Lot Numbers: 24CBO655; k) DYNJ908110B: UDI/DI case 40195327507160, UDI/DI each 10195327507169, Lot Numbers: 24ABS361, 24CBE409; m) DYNJ908425: UDI/DI case 40195327072613, UDI/DI each 10195327072612, Lot Numbers: 24ABL204; n) DYNJ908660A: UDI/DI case 40195327219674, UDI/DI each 10195327219673, Lot Numbers: 23LMC113, 24AME301, 24AMJ018, 24CMH075; o) DYNJ909734: UDI/DI case 40195327464708, UDI/DI each 10195327464707, Lot Numbers: 24ABA222, 24CBO720; p) DYNJ909738: UDI/DI case 40195327464739, UDI/DI each 10195327464738, Lot Numbers: 24ABY029, 4EBH232; q) DYNJ909740: UDI/DI case 40195327464753, UDI/DI each 10195327464752, Lot Numbers: 24BBK598; r) DYNJ910074A: UDI/DI case 40195327639281, UDI/DI each 10195327639280, Lot Numbers: 24CBA353; s) DYNJ910077: UDI/DI case 40195327568383, UDI/DI each 10195327568382, Lot Numbers: 23LBS081; t) DYNJ910077A: UDI/DI case 40195327639342, UDI/DI each 10195327639341, Lot Numbers: 24CBM378, 24DBC165; u) DYNJ910080A: UDI/DI case 40195327639304, UDI/DI each 10195327639303, Lot Numbers: 24BBS375; v) DYNJ910370: UDI/DI case 40195327654536, UDI/DI each 10195327654535, Lot Numbers: 24DDB322, 24EDA091; w) DYNJC9311L: UDI/DI case 40195327464777, UDI/DI each 10195327464776, Lot Numbers: 24CDC175
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 95128This product is part of a recall event; the main page for the event is Medline convenience kits containing semi-rigid suction recalled.
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