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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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Low RiskFDA Device
Medical Devices/Home Healthcare

Fresenius Medical Care Holdings, Inc.: Liberty Select Cycler Recalled for Incorrect Treatment Report Time Stamps

Agency Publication Date: December 26, 2023
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Summary

Fresenius Medical Care Holdings, Inc. is recalling 149 Liberty Select Cyclers, specifically model numbers RTLR180343 and RTLR180111, because they may display an incorrect time stamp on treatment data reports sent to clinics. While the dialysis treatment itself is not affected, the inaccurate reporting of when a treatment occurred could lead to confusion or errors in clinical records. This voluntary recall involves specific serial numbers distributed across 20 U.S. states. Consumers should contact their healthcare provider or the manufacturer to discuss any concerns regarding their treatment reports.

Risk

The incorrect time stamps on clinical reports could lead to medical staff misinterpreting when a patient's dialysis was performed. This poses a low risk but could potentially impact the synchronization of care or clinical decision-making based on inaccurate data logs.

What You Should Do

  1. Identify if your device is affected by checking the model number (RTLR180343 or RTLR180111) and the serial number on the back or side of the unit.
  2. Check your serial number against the 149 affected units, which include: LC002956, LC102178, LC021724, LC107205, LC023197, LC021734, LC017434, LC108957, LC022069, LC103031, LC006834, LC022218, LC017378, LC026229, LC022262, LC104084, LC005140, LC022616, LC019115, LC021388, LC024210, LC108220, LC020906, LC024377, LC023711, LC121383, LC025541, LC118552, LC010607, LC025545, LC015082, LC111682, LC026353, LC114222, LC105047, LC102656, LC113355, LC104022, LC103069, LC115736, LC109288, LC104268, LC016965, LC121349, LC104371, LC105964, LC003341, LC104630, LC016669, LC113929, LC105108, LC020357, LC111447, LC105656, LC003460, LC112030, LC105951, LC107408, LC025450, LC106453, LC109867, LC012490, LC107813, LC108319, LC106079, LC108527, LC106667, LC122086, LC108652, LC110922, LC119859, LC108929, LC022708, LC010574, LC108988, LC113343, LC118563, LC109815, LC000539, LC105216, LC110210, LC108637, LC103326, LC112490, LC103658, LC104946, LC112954, LC024150, LC017621, LC113920, LC017046, LC017185, LC114230, LC022051, LC010500, LC117266, LC001887, LC002982, LC117324, LC102332, LC106468, LC117470, LC007590, LC100108, LC118836, LC016220, LC101309, LC120508, LC018125, LC010096, LC121590, LC022514, LC018533, LC121788, LC009410, LC002257, LC122822, LC105569, LC002521, LC116979, LC004607, LC006643, LC004836, LC109482, LC008971, LC115908, LC009077, LC123137, LC010282, LC102959, LC010363, LC020163, LC011334, LC107982, LC013964, LC118817, LC015496, LC118029, LC015554, LC119978, LC017329, LC104633, LC017436, LC020459, LC019811, LC110544, LC020468, LC113118, and LC021140.
  3. If your cycler is one of the affected serial numbers, contact your healthcare provider or Fresenius Medical Care Holdings, Inc. at 1-800-323-5188 for further instructions regarding the treatment data reporting issue.
  4. Continue following your prescribed dialysis treatment as the physical operation of the cycler is not impacted by this data reporting error.
  5. For additional questions or concerns, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Information provided via firm notification letter

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

Affected Products

Product: Liberty Select Cycler
Model / REF:
RTLR180343
RTLR180111
UPC Codes:
00840861102068
Lot Numbers (149):
LC002956
LC102178
LC021724
LC107205
LC023197
LC021734
LC017434
LC108957
LC022069
LC103031
LC006834
LC022218
LC017378
LC026229
LC022262
LC104084
LC005140
LC022616
LC019115
LC021388
LC024210
LC108220
LC020906
LC024377
LC023711
LC121383
LC025541
LC118552
LC010607
LC025545
LC015082
LC111682
LC026353
LC114222
LC105047
LC102656
LC113355
LC104022
LC103069
LC115736
LC109288
LC104268
LC016965
LC121349
LC104371
LC105964
LC003341
LC104630
LC016669
LC113929

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93579
Status: Active
Manufacturer: Fresenius Medical Care Holdings, Inc.
Sold By: Direct distribution to clinics
Manufactured In: United States
Units Affected: 149 US
Distributed To: Alabama, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Montana, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia

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.