Stryker SLCD12Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07798164678175), received between Dec 26, 2023 and Jan 10, 2024 — classified as 15 malfunctions.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WERE RECURRING BIS FOLLOWING COMPLETED VP4 CYCLES. THE VP4 DID NOT REGISTER ANY ERROR CODES OR CANCEL ANY LOADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18485754 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER THAT THE INCUBATOR HAS SOME PORTS NOT WORKING PROPERLY. THE DEVICE WAS SENT BACK TO THE DISTRIBUTOR BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475644 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, THE AUTOREADER WAS BROKEN. NOTICED DURING TESTING. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475002 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, THE AUTOREADER INCUBATOR WAS NOT WORKING DURING TESTING. PRODUCT WAS SCRAPPED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474940 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AUTOREADER INCUBATOR'S TOUCH SCREEN WAS UNRESPONSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474830 ↗
• MalfunctionJan 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, THE INCUBATOR WOULD NOT TURN ON. NOTICED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474341 ↗
• MalfunctionJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED THAT AN AUTOREADER WOULD NOT BOOT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435983 ↗
• MalfunctionJan 3, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE DISTRIBUTOR REPRESENTATIVE, THE AUTOREADER INCUBATOR WOULD NOT GET TO THE WORKING TEMPERATURE, WHICH WOULD NOT LET THE AUTOREADER START ANY BIOLOGICAL INDICATOR INCUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434242 ↗
• MalfunctionJan 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED MALFUNCTIONING OF THE AUTOREADER INCUBATOR BECAUSE OF POSITIVE RESULTS OBTAINED WITH THE BIOLOGICAL INDICATOR AFTER STERILIZATION PROCESS IN THE VP4 EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18428637 ↗
• MalfunctionDec 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE DISTRIBUTOR REPRESENTATIVE, THE AUTOREADER INCUBATOR WOULD NOT BOOT UP, SINCE IT WAS STUCK IN THE LOADING SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418819 ↗
• MalfunctionDec 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE USER, THE AUTOREADER INCUBATOR KEPT SHOWING POSITIVE RESULTS FOR THE BIOLOGICAL INDICATORS AFTER THE STERILIZATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418556 ↗
• MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER INDICATED THAT THE INCUBATOR WAS NOT CALIBRATING CORRECTLY BECAUSE THE HUB WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398363 ↗
• MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AUTO READER INCUBATOR WAS NOT DETECTING THE BIOLOGICAL INDICATORS AND GIVING FALSE NEGATIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397839 ↗
• MalfunctionDec 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PERSONNEL OF THE UNIVERSITY OF UTAH INDICATED THAT BIOLOGICAL INDICATORS KEPT SHOWING POSITIVE RESULTS AFTER THE STERILIZATION PROCESS. THEY MENTIONED THAT TECHNICIANS MADE MULTIPL ATTEMPTS TO REPAIR THE STERILIZER BUT TO NO AVAIL AND CONCLUDED THAT THE INCUBATOR WAS NOT WORKING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397481 ↗
• MalfunctionDec 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE OF THE INCUBATOR WELLS WAS GIVING FALSE POSITIVE READOUTS OF THE BIOLOGICAL INDICATORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394590 ↗