MaxGuardRecalls & reported problems across all models

We found 49 models of MaxGuard by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 780 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 24, 2026 — classified as 6 injuries, 774 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (162 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MaxGuard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 16, 2026Open, Classified

   Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.

   Z-2941-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Oct 11, 2023Open, Classified

   Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

   Z-0351-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

3. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1760-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

4. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1759-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

5. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1758-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

6. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1757-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

7. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1756-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

8. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1755-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

9. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1754-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

10. Aug 1, 2022Open, Classified

    Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

    Z-1753-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

11. Aug 1, 2022Open, Classified

    Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

    Z-1752-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported MaxGuard problems

MaxGuard models

49 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MaxGuard ME2017

  Set, administration, intravascular
  137 reports
• MaxGuard ME2020

  Set, administration, intravascular
  94 reports
• MaxGuard ME1224

  Set, administration, intravascular
  1 recall43 reports
• MaxGuard MFS141

  Set, administration, intravascular
  1 recall40 reports
• MaxGuard MX4436

  Set, administration, intravascular
  1 recall30 reports
• MaxGuard MX9166

  Set, administration, intravascular
  1 recall23 reports
• MaxGuard ME2010

  Set, administration, intravascular
  1 recall19 reports
• MaxGuard MX9433

  Set, administration, intravascular
  1 recall15 reports
• MaxGuard MX9059

  Set, administration, intravascular
  1 recall8 reports
• MaxGuard MX9171

  Set, administration, intravascular
  1 recall7 reports
• MaxGuard MX4439

  Set, administration, intravascular
  54 reports
• MaxGuard MFS106

  Set, administration, intravascular
  1 recall2 reports
• MaxGuard M4058

  Set, administration, intravascular
  1 recall0 reports
• MaxGuard ME1069

  Set, administration, intravascular
  1 recall0 reports
• MaxGuard ME5303

  Set, administration, intravascular
  47 reports
• MaxGuard MX4452

  Set, administration, intravascular
  35 reports
• MaxGuard MX9128

  Set, administration, intravascular
  29 reports
• MaxGuard MX4450

  Set, administration, intravascular
  22 reports
• MaxGuard MX5301

  Set, administration, intravascular
  18 reports
• MaxGuard MX9968

  Set, administration, intravascular
  14 reports
• MaxGuard ME2064

  Set, administration, intravascular
  13 reports
• MaxGuard ME1225

  Set, administration, intravascular
  11 reports
• MaxGuard MFS102

  Set, administration, intravascular
  11 reports
• MaxGuard MA3131

  Set, administration, intravascular
  10 reports
• MaxGuard ME2050

  Set, administration, intravascular
  10 reports
• MaxGuard MX5302

  Set, administration, intravascular
  10 reports
• MaxGuard ME1021

  Set, administration, intravascular
  8 reports
• MaxGuard MX9060

  Set, administration, intravascular
  7 reports
• MaxGuard MXT1003

  Set, administration, intravascular
  7 reports
• MaxGuard ME1055

  Set, administration, intravascular
  6 reports
• MaxGuard ME1110

  Set, administration, intravascular
  6 reports
• MaxGuard M4018

  Set, administration, intravascular
  5 reports
• MaxGuard ME1001

  Set, administration, intravascular
  5 reports
• MaxGuard ME5301

  Set, administration, intravascular
  4 reports
• MaxGuard ME2068

  Set, administration, intravascular
  4 reports
• MaxGuard ME1247

  Set, administration, intravascular
  3 reports
• MaxGuard ME1032

  Set, administration, intravascular
  2 reports
• MaxGuard ME1046

  Set, administration, intravascular
  2 reports
• MaxGuard ME1048

  Set, administration, intravascular
  2 reports
• MaxGuard ME2059

  Set, administration, intravascular
  2 reports
• MaxGuard ME5302

  Set, administration, intravascular
  2 reports
• MaxGuard MFS124

  Set, administration, intravascular
  2 reports
• MaxGuard MFS132

  Set, administration, intravascular
  2 reports
• MaxGuard MX4410

  Set, administration, intravascular
  2 reports
• MaxGuard MX4457

  Set, administration, intravascular
  2 reports
• MaxGuard MX9182

  Set, administration, intravascular
  2 reports
• MaxGuard ME1227

  Set, administration, intravascular
  1 report
• MaxGuard MM4000

  Set, administration, intravascular
  1 report
• MaxGuard MXT1006

  Set, administration, intravascular
  1 report

Recent MaxGuard adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Contamination /Decontamination Problem

  It was reported that BD alaris extension set had foreign matter The following information was received by the initial reporter with the following VerbatimIt was reported by customer that the Black speck present within the tubing line.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876666 ↗
• MalfunctionSep 22, 2026Free or Unrestricted Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861493 ↗
• MalfunctionSep 21, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846895 ↗
• MalfunctionSep 9, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50702904 ↗
• MalfunctionAug 25, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422105 ↗
• MalfunctionAug 17, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50287846 ↗
• MalfunctionJun 30, 2026Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THEY PULLED BACK FROM THE OPEN END OF THE EXTENSION TUBING TO WASTE BLOOD, AND BLOOD AND SALINE BEGIN LEAKING OUT OF THE Y-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667852 ↗
• MalfunctionJun 30, 2026Backflow

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET W/ NEEDLELESS Y-SITE HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS REPORTED ISSUES OF THE BACKCHECK VALVE ON THE MX9182 NOT WORKING CORRECTLY. HE HAS SAVED THE SAMPLE AND HAS THE LOT # INFORMATION AS WELL. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU PLEASE PROVIDE A DETAILED DESCRIPTION OF THE ISSUE YOU ENCOUNTERED WITH BACKCHECK VALVE ON THE MX9182? WE IDENTIFIED AN ISSUE WITH THE BACKCHECK VALVE¿S INTENDED ONE WAY VALVE. WHEN SLIGHT POSITIVE PRESSURE IS APPLIED ON THE BACKCHECK SIDE OF THE VALVE SUCH AS DURING MEDICATION INFUSION, FLUSHING, OR MANUAL INJECTION THROUGH A LUER-LOCK ACCESS PORT THE VALVE DOES NOT CONSISTENTLY PREVENT RETROGRADE FLOW. UNDER THESE CONDITIONS, THE APPLIED PRESSURE APPEARS TO BYPASS THE VALVE DIAPHRAGM, ALLOWING FLUID TO TRAVEL BACKWARD INTO THE UPSTREAM LINE. THIS OCCURS WITH MINIMAL FORCE, CONSISTENT WITH NORMAL FLUSHING OR MEDICATION ADMINISTRATION, AND DOES NOT REQUIRE EXCESSIVE PRESSURE. AS A RESULT, THE VALVE FAILS TO RELIABLY MAINTAIN DIRECTIONAL FLOW AS DESIGNED. THIS BEHAVIOR CREATES THE POTENTIAL FOR UNINTENDED BACKFLOW INTO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667849 ↗
• MalfunctionJun 26, 2026Disconnection

  IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SITE KEEPS COMING UNHOOKED FROM THE PATIENTS. IT HAS HAPPENED 3 TIMES. INJURIES OR ADVERSE EVENT: YES. ITEM: MX5302, QUANTITY AFFECTED: 3 EA, SERIAL/LOT NUMBER: (B)(6), ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? N/A.

  Patient problems: Insufficient Information

  MAUDE report 25640521 ↗
• MalfunctionJun 11, 2026Material Twisted/Bent

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474088 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474085 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE SYRINGE TUBING AND LODGED WITHIN THE IV CLAVE. THEY WERE UNABLE TO REMOVE IT, WHICH ULTIMATELY REQUIRED THE ENTIRE CLAVE TO BE CHANGED ON A PEDIATRIC IV. ALSO, THE TUBING IS TIGHTLY COILED WITHIN THE PACKAGING, AND WHEN OPENED QUICKLY, IT TENDS TO BECOME TANGLED AND DIFFICULT TO UNRAVEL. THIS CREATES DELAYS AND FRUSTRATION DURING PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473298 ↗
• MalfunctionJun 8, 2026Leak/Splash

  IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS SEPARATEDTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT "INFUSION SET'S TUBING MAY SEPARATE, LEAK, OR FAIL TO PRIME"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437686 ↗
• MalfunctionApr 23, 2026Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOCKAGE ISSUES WERE IDENTIFIED ON OPENED ITEMS. INJURIES OR ADVERSE EVENT: NO, ITEM: MX5301, SERIAL/LOT NUMBER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974360 ↗
• MalfunctionApr 7, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED BY CUSTOMER THAT THE END THAT ATTACHES TO THE IV PRIMARY LINE CAME APART FROM THE TUBING.

  Patient problems: Insufficient Information

  MAUDE report 24802763 ↗

Other BD Switzerland Sàrl products

• Alaris, SmartSite160 models · 10,227 reports · 8 recalls
• Alaris85 models · 2,797 reports · 10 recalls
• MaxZero47 models · 2,377 reports
• BD PhaSeal23 models · 992 reports · 2 recalls
• MaxPlus18 models · 762 reports · 2 recalls
• BD SmartSite29 models · 568 reports · 4 recalls
• Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
• BD PhaSeal Optima11 models · 474 reports · 1 recall