RegWardenFDA facility compliance records
Facility

MEDIMEXICO, S. DE R.L. DE C.V.

57 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 3 recalls; 2013: 7 recalls; 2014: 8 recalls; 2015: 4 recalls; 2020: 7 recalls; 2021: 4 recalls; 2022: 7 recalls; 2023: 4 recalls; 2024: 7 recalls; 2025: 3 recalls; 2026: 3 recalls3’127’138’144’15’16’17’18’197’204’217’224’237’243’253’26
  • Recalls (57)

Devices registered here (1)

  • Dialyzer, High Permeability With Or Without Sealed Dialysate System
    Product code KDI (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5860

Recalls & enforcement

20263 records
  • Class IIOngoing2026-05-12
    Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for t…
  • Class IIOngoing2026-05-11
    Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
  • Class IIOngoing2026-05-07
    There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as…
20253 records
  • Class IIOngoing2025-10-25
    Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
  • Class IIOngoing2025-08-29
    To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.
  • Class IIOngoing2025-04-29
    Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
20247 records
  • Class IIOngoing2024-12-05
    Potential for internal blood leaks due to cracked polyurethane
  • Class IIOngoing2024-08-08
    Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.
  • Class IIOngoing2024-06-03
    An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
  • Class IIOngoing2024-05-16
    Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
  • Class IIOngoing2024-04-17
    An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
  • Class IIOngoing2024-04-08
    Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
  • Class IOngoing2024-01-23
    The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
20234 records
20227 records
  • Class IIOngoing2022-10-04
    The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.
  • Class IIOngoing2022-07-27
    (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
  • Class IIOngoing2022-06-21
    Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
  • Class IIOngoing2022-06-16
    Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service techni…
  • Class IITerminated2022-06-01
    The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
  • Class IIOngoing2022-05-31
    Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use
  • Class IITerminated2022-05-04
    Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
20214 records
  • Class IIOngoing2021-12-07
    Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled…
  • Class IITerminated2021-08-03
    AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may …
  • Class IITerminated2021-04-28
    Exposed to freezing temperatures due to refrigerated truck malfunctions
  • Class IITerminated2021-03-18
    AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may …
20207 records
  • Class IITerminated2020-12-17
    Bottles Missing Product Label
  • Class IIOngoing2020-11-23
    The deviation in conductivity for sodium level exceeds 0.6mS/cm from the theoretical conductivity (TCD) or approximately 6mEq/L of sodium from prescriptions that was previously communicated. Calcium concentration is below manufacturing specification.
  • Class IIOngoing2020-11-07
    The sodium and/or calcium levels in these concentrates were below the manufacturing specifications.
  • Class IICompleted2020-09-12
    The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked' alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra fluid is present and it will not make it …
  • Class IITerminated2020-09-01
    Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially res…
  • Class IIOngoing2020-03-12
    A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
  • Class IITerminated2020-01-29
    The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.
20154 records
20148 records
20137 records
  • Class IITerminated2013-12-17
    Bicarbonate Jug Adapter distributed prior to 510(k) approval
  • Class IITerminated2013-11-12
    2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
  • Class IITerminated2013-10-14
    Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
  • Class IITerminated2013-08-29
    Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
  • Class IITerminated2013-06-03
    Cassette may leak during set up or during peritoneal dialysis treatment
  • Class IITerminated2013-05-24
    Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
  • Class IITerminated2013-04-01
    Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over…
20123 records

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDIMEXICO, S. DE R.L. DE C.V. (FEI 3002654698) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002654698-medimexico-s-de-r-l-de-c-v/

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