PremierProRecalls & reported problems across all models

We found 13 models of PremierPro by Prestige Ameritech, Ltd. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2019 and May 6, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 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

PremierPro 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. May 13, 2024Class IIOpen, Classified

   Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).

   Z-2320-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

Most reported PremierPro problems

PremierPro models

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

• PremierPro D5061

  Patient Examination Glove, Specialty
  1 recall0 reports
• PremierPro D5062

  Patient Examination Glove, Specialty
  1 recall0 reports
• PremierPro D5063

  Patient Examination Glove, Specialty
  1 recall0 reports
• PremierPro D5064

  Patient Examination Glove, Specialty
  1 recall0 reports
• PremierPro D5065

  Patient Examination Glove, Specialty
  1 recall0 reports
• PremierPro 8326B

  Drape, Surgical
  3 reports
• PremierPro X8435

  Gauze/Sponge, Internal, X-Ray Detectable
  2 reports
• PremierPro™ 31T20116

  Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
  1 report
• PremierPro™ 31TB20100

  Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
  1 report
• PremierPro 5063

  Patient Examination Glove, Specialty
  1 report
• PremierPro 5064

  Patient Examination Glove, Specialty
  1 report
• PremierPro 5042

  Patient Examination Glove, Specialty
  1 report
• PremierPro 8808

  Infusor, Pressure, For I.V. Bags
  1 report

Recent PremierPro adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026

  THE STERILE OR TOWELS FROM PREMIERPRO ARE HAVING AN ISSUE WITH EXTRA LINT THAT IS TRANSFERRING TO WIRES WHEN WET. LOTS OF LINT COMING OFF TOWELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092856 ↗
• MalfunctionMar 19, 2026

  THE PACK OF LAPS WAS NOTED TO BE MISSING THE BLUE LOOPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639326 ↗
• MalfunctionAug 6, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED; THE BAG DID NOT HOLD PRESSURE DURING THE PROCEDURE; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22734540 ↗
• MalfunctionJan 17, 2025Component Misassembled; Component Misassembled

  I WAS STARTING AN IV ON A PATIENT, AND WHEN I HIT THE NEEDLE RETRACT BUTTON, THE NEEDLE FLEW OUT THE BACK END AND HIT ME IN THE LEG. I DID NOT SEE ANY MARKS THAT MAKE ME THINK THE NEEDLE STUCK ME, I AM PRETTY CERTAIN I GOT HIT WITH THE BACK END OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182150 ↗
• MalfunctionNov 14, 2024

  REGISTERED NURSE (RN) WENT TO GRAB CHEMO GLOVES OUT OF BOX AND GLOVE RIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683030 ↗
• MalfunctionSep 16, 2024

  GLOVES RIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223642 ↗
• MalfunctionJun 26, 2024Disconnection; Loose or Intermittent Connection; Product Quality Problem; Difficult to Remove; Retraction Problem; Failure to Advance

  MULTIPLE ISSUES WITH THE TRUESAFE COMFORT BLOOD CONTROL IV CATHETER. REPORTS CONTAIN ALL GAUGE CATHETERS. VARIOUS COMPLAINTS: 1. CATHETER WOULD NOT ADVANCE 2. CATHETER RETRACTED EARLY CAUSING THE VEIN TO BLOW 3. INFILTRATIONS 4. CATHETER DOES NOT CONNECT TO TUBING CONNECTION WELL 5. DURING PRESSURE INJECTION CT; THE CATHETER AND CONNECTION DISCONNECT. 6. IV NEED WOULD NOT RETRACT AFTER STARTING IV. HAD TO PULL THE ENTIRE DEVICE OUT OF THE PATIENT'S ARM TO RETRACT THE NEEDLE.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 19613246 ↗
• MalfunctionApr 30, 2024

  FOREIGN OBJECT IN STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212480 ↗
• MalfunctionSep 25, 2023

  WHEN OPENING A PACK OF STERILE SINGLE USE TOWELS, DEBRIS OF UNKNOWN ORIGIN, SIMILAR TO HAIR, WAS FOUND IN THE WEAVE OF THE TOWEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806928 ↗
• MalfunctionJun 17, 2021Contamination

  CIRCULATOR PASSED SCRUB TECH A PACK OF LAP SPONGES USING STERILE TECHNIQUE. WHEN SCRUB STARTED TO COUNT THE LAPS, SHE NOTICED A HAIR BETWEEN TWO OF THEM. TECH HANDED THE LAPS BACK TO CIRCULATOR AND REMOVED HER OUTER GLOVES. TECH DONNED NEW OUTER GLOVES. PACKAGING AND LAPS SAVED.

  Patient problems: Insufficient Information

  MAUDE report 12016404 ↗
• MalfunctionAug 23, 2019Material Split, Cut or Torn

  GLOVE TORE WHEN PUTTING ON DURING CASE. RECURRING PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926207 ↗