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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Medline Suction Liners and Convenience Kits Recalled for Suction Loss

Agency Publication Date: September 11, 2024
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Summary

Medline Industries is recalling over 1.29 million semi-rigid suction liners and convenience kits containing these liners because they may lose suction or have low suction performance. These medical devices, manufactured between September 2023 and November 2023, are used in clinical settings to remove fluids, and several adverse events have already been reported. The recall affects a wide range of surgical and procedural kits, including those for anesthesia, heart surgery, endoscopy, and pediatric care. Consumers and healthcare providers should identify affected lots immediately and contact the manufacturer for further instructions.

Risk

The potential loss of suction or low suction performance during use can prevent the effective removal of fluids from a patient's airway or surgical site. This defect poses a risk of choking, aspiration, or delayed medical procedures which could lead to serious patient harm.

What You Should Do

  1. Check your inventory for Medline Semi-rigid suction liners with reference numbers OR515, OR526K, OR527K, and OR529K, specifically looking for lot numbers starting with '93023' or '93024'.
  2. Identify if you have any surgical or 'convenience' kits containing these liners, such as Anesthesia Circuits, Open Heart Kits, Endo Kits, or NICU Admit Kits (see the full list of over 50 specific kit names in the product details).
  3. Verify the Lot Number and UDI/DI on the product packaging; affected lots include codes such as 24DBV950, 24CLA959, 24BMI437, 23LMI232, and 24CBK289 among many others manufactured late 2023.
  4. Stop using the affected suction liners and kits immediately to avoid potential complications from suction failure.
  5. Contact your healthcare provider if you have concerns about procedures where these devices may have been used, or contact Medline Industries directly at their Northfield, Illinois headquarters for return or replacement instructions.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Advisory and investigation into device failure

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medline Semi-rigid suction liner (1500 cc)
Model / REF:
OR515
OR526K
OR527K
OR529K
Lot Numbers (85):
93023082618C
93023082730C
93023090602C
93023090902C
93023091309C
93023091409C
93023091428C
93023091506C
93023091609C
93023091806C
93023093A10C
93023098426C
93023098623C
93023098811C
93023099605C
93023099705C
93023099806C
93023099826C
93023102613C
93023102718C
93023102815C
93023102920C
93023103015C
93023103120C
93023103316C
93023103B08C
93023106628C
93023106721C
93023107028C
93023107225C
93023108512C
93023108712C
93023112721C
93023112828C
93023113027C
93023113327C
93023113626C
93023113C12C
93023116906C
93023117013C
93023117106C
93023117118C
93023117212C
93023117301C
93023117317C
93023117401C
93023117420C
93023117506C
93023117512C
93023117618C
Product: Medline Convenience Kits (Anesthesia, Endo, Surgical)
Model / REF (89):
DYNJAA0311C
DYNJAA0323C
DYNJAA0378A
DYNJAA10579
DYNJAAF6674I
DYK1002174I
DYKE1558B
DYKE1804A
DYNJ900714C
DYNJ905472B
DYNJ908096A
DYNJ909451A
DYKE1456D
DYNJ908099B
DYNJ908101B
DYNJ908105B
DYNJ908429
DYNJ909948
CDS981509C
CDS981512J
CDS981515D
DYNJ900709C
DYNJ900709D
DYNJ900723C
DYNJ900723D
DYNJ908098A
DYNJ908428
DYNJ909730
DYKE1355
DYKE1356
DYKE1771C
DYKE1350D
DYKE1514B
DYNJ908104B
DYNJ908106B
DYNJ909946
DYNJ909951
DYKE1092B
DYKE1666
DYKM2196
DYKM2196H
DYNJ24810B
DYNJ907991F
DYNJ908108A
DYNJ908109C
DYNJ908748D
DYNJ908750D
DYNJ909731
DYNJ909735
DYNJ909945
Lot Numbers (180):
24DBV950
24CBL800
24BBI902
23LBT319
24DBM735
24DBN216
24CBI422
24CBJ132
23KBU156
24DBQ840
24DBQ839
24DBB513
24ABM732
24ABU331
24ABU330
24ABQ036
24ABK802
24ABF565
24ABG771
23LBN692
23LBL609
23KBU727
23LBL288
24DBM458
24CBS798
24CBO294
23LBV673
24CLA959
24DMA783
24BMG878
23LMG790
24BMI437
24AME311
23LMC958
24FBC609
24BBS291
24ABX948
24ABB080
23LMI232
24CBK289
24BBK989
24DBI371
24BBA188
24CBE408
24BBA260
24ABB112
24ABV362
24CBB310
23LBV007
24DBD609

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95128
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 17 products (1,250,374 units; 29,585 units; 1,646 units; 19 units; 407 units; 358 units; 6257 units; 1616 units; 350 units; 3117 units; 444 units; 1800 units; 134 units; 55 units; 35 units; 720 units; 1076 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.