Z-3121-2024Class II

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack...

Name: Z-3121-2024 Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-06-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-06-27 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L; b) ORTHO TRAUMA-LF, Pack Number... on 2024-06-27. FDA classified it as Class II and gives the reason as "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...". 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-3121-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-27
Posted: 2024-09-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: OJH Orthopedic Tray
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 1076 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3121-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3105-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3106-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3107-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3108-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3109-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3110-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3111-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3112-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3113-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3114-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3115-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3116-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3117-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3118-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3119-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3120-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3121-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11

Product code OJH

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)