SureStep Male External Catheter System Orange Replacement Kit MECRR030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741183645), received between Aug 10, 2022 and Aug 10, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE CUSTOMER HAD COME ACROSS A PRODUCT LABELING ERROR WITH SURESTEP MALE EXTERNAL CATHETER. CUSTOMER STATED THAT THE PLASTIC ROUND PIECE WAS SUPPOSED TO BE LABELED 1 HOWEVER THEY WERE LABELED 2 INSTEAD. CUSTOMER HAS 2 FULL CASES OF LOT# JUGS9085 WITH THE INCORRECT NUMBER AND ALSO LOT# JUGS0436 AND LOT# JUGS9259. THEY THOUGHT THIS WAS NOT A DEFECTIVE ISSUE BUT BELIEVED MANUFACTURING HAD A SHORTAGE IN THE WHITE PLASTIC HOLDER FOR THE NEW CONDOM CATHETERS. IT LOOKED LIKE THEY USED ONES WITH AN INTERNAL LABELING OF ¿2¿ INSTEAD OD ¿1¿ BECAUSE OF A SHORTAGE IN PACKAGING PARTS. CUSTOMER WAS USING THIS SMALL NUMBER AS A MEANS OF SIZING EVEN THOUGH IT WAS NOT LISTED ON THE DFU (DIRECTIONS FOR USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204446 ↗
• MalfunctionAug 10, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE CUSTOMER HAD COME ACROSS A PRODUCT LABELING ERROR WITH SURESTEP MALE EXTERNAL CATHETER. CUSTOMER STATED THAT THE PLASTIC ROUND PIECE WAS SUPPOSED TO BE LABELED 1 HOWEVER THEY WERE LABELED 2 INSTEAD. CUSTOMER HAS 2 FULL CASES OF LOT# JUGS9085 WITH THE INCORRECT NUMBER AND ALSO LOT# JUGS0436 AND LOT# JUGS9259. THEY THOUGHT THIS WAS NOT A DEFECTIVE ISSUE BUT BELIEVED MANUFACTURING HAD A SHORTAGE IN THE WHITE PLASTIC HOLDER FOR THE NEW CONDOM CATHETERS. IT LOOKED LIKE THEY USED ONES WITH AN INTERNAL LABELING OF ¿2¿ INSTEAD OF ¿1¿ BECAUSE OF A SHORTAGE IN PACKAGING PARTS. CUSTOMER WAS USING THIS SMALL NUMBER AS A MEANS OF SIZING EVEN THOUGH IT WAS NOT LISTED ON THE DFU (DIRECTIONS FOR USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199065 ↗
• MalfunctionAug 10, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE CUSTOMER HAD COME ACROSS A PRODUCT LABELING ERROR WITH SURESTEP MALE EXTERNAL CATHETER. CUSTOMER STATED THAT THE PLASTIC ROUND PIECE WAS SUPPOSED TO BE LABELED 1 HOWEVER THEY WERE LABELED 2 INSTEAD. CUSTOMER HAS 2 FULL CASES OF LOT#: JUGS9085 WITH THE INCORRECT NUMBER AND ALSO LOT#: JUGS0436 AND LOT#: JUGS9259. THEY THOUGHT THIS WAS NOT A DEFECTIVE ISSUE BUT BELIEVED MANUFACTURING HAD A SHORTAGE IN THE WHITE PLASTIC HOLDER FOR THE NEW CONDOM CATHETERS. IT LOOKED LIKE THEY USED ONES WITH AN INTERNAL LABELING OF ¿2¿ INSTEAD OF ¿1¿ BECAUSE OF A SHORTAGE IN PACKAGING PARTS. CUSTOMER WAS USING THIS SMALL NUMBER AS A MEANS OF SIZING EVEN THOUGH IT WAS NOT LISTED ON THE DFU (DIRECTIONS FOR USE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199064 ↗