WANG SW-221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20653405052699), received between Oct 17, 2016 and Aug 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K914181); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Retraction Problem

  DURING A FINE NEEDLE ASPIRATION/ LUNG BIOPSY, THE NEEDLE DID NOT RETRACT AFTER OBTAINING THE SPECIMEN. THE PHYSICIAN HAD TO REMOVE THE SCOPE WITH THE PROTRUDING NEEDLE AND TO REPLACE IT. THIS HAS POTENTIAL TO CAUSE SERIOUS HARM TO A PATIENT. THE REMAINING KITS WERE REMOVED FROM THE SHELVES AND A DIFFERENT BRAND WILL BE USED. THIS IS NOT THE FIRST CASE THAT HAD ISSUES WITH THIS EQUIPMENT. THERE WAS NO PATIENT HARM FOR THIS EVENT. THE USED EQUIPMENT WILL BE RETAINED BY THE HOSPITAL PURCHASING DEPARTMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8887536 ↗
• MalfunctionOct 17, 2016Device Packaging Compromised

  THE USER FACILITY REPORTED THAT THE SW-221 WANG CYTOLOGY NEEDLE WAS RECEIVED WITH THE POUCH NOT SEALED. TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6033448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914181. One submission often covers many models, so check the product and lot details in each record.

• Z-0503-2013 · Nov 20, 2012 · Terminated
  WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (fle
• Z-0505-2013 · Nov 20, 2012 · Terminated
  WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or
• Z-0504-2013 · Nov 20, 2012 · Terminated
  WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (f
• Z-0502-2013 · Nov 20, 2012 · Terminated
  WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or