FDA (Devices) recall action 92466
The FDA (Devices) publishes a recall like this one as 52 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 52 pages.
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling ultrasound probe cover kits due to inadequate barriers at the seams. The defect may allow contaminants to reach the patient during diagnostic ultrasound procedures.
Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.
Medline is recalling Probe Cover Kits because probe covers may have inadequate seam barriers that could allow contamination during ultrasound procedures. Approximately 24,192 units were distributed worldwide from December 2017 to May 2023.
Medline Probe Cover Kits used during ultrasound procedures may have an inadequate barrier at the seams that could compromise sterility. The manufacturer is recalling 180 units distributed worldwide between December 2017 and May 2023.
Medline is recalling 4,398 probe cover kits used in ultrasound procedures due to inadequate seam barriers that may compromise sterility. The kits were distributed worldwide from December 2017 through May 2023.
Medline is recalling 173,449 sterile probe cover kits due to inadequate seam barriers that may compromise sterility. The affected units were distributed worldwide between December 2017 and May 2023.
Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound procedures.
Medline is recalling 770,147 ultrasound probe cover kits worldwide due to inadequate barriers at the seams. The defect could allow contamination during diagnostic ultrasound procedures.
Medline probe cover kits used in diagnostic ultrasound procedures may have inadequate barriers at the seams. The recall affects 540 units distributed worldwide between December 2017 and May 2023.
Medline is recalling ultrasound probe cover kits with sterile gel due to inadequate seam barriers that may compromise sterility during diagnostic procedures. Approximately 8,974 units distributed worldwide from 2017 to 2023 are affected.
Medline is recalling Probe Cover Kits (model DYNJ60126B) with an inadequate barrier at the seams that may compromise sterile protection during ultrasound procedures. The kits were distributed worldwide between December 2017 and May 2023.
Medline is recalling 2,304 probe cover kits because the seams may not provide adequate barrier protection during ultrasound procedures. Affected kits were distributed worldwide from December 2017 to May 2023.
Medline is recalling 10,080 ultrasound probe cover kits because the seams may not seal properly, potentially compromising barrier protection. The kits were distributed worldwide from December 2017 through May 2023.
Medline is recalling probe cover kits with ultrasound gel due to inadequate barriers at the seams that may compromise sterility during diagnostic ultrasound procedures.
Medline Industries is recalling approximately 23,938 units of sterile ultrasound probe cover kits distributed worldwide from December 2017 to May 2023 due to inadequate barriers at seams that could compromise sterility during diagnostic ultrasound procedures.
Medline is recalling Probe Cover Kits (Models CVI4325 and DT13351A) distributed worldwide from December 2017 to May 2023. The probe covers may have inadequate barrier protection at the seams, posing a contamination risk during diagnostic ultrasound procedures.
Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units distributed worldwide between December 2017 and May 2023.
Medline probe cover kits used in diagnostic ultrasound procedures are being recalled due to inadequate barriers at the seams, which may compromise sterile integrity during use. A total of 39,391 units are affected.
Medline Probe Cover Kits used in diagnostic ultrasound procedures are recalled because probe covers may have an inadequate barrier at the seams, potentially allowing contamination.
Medline Industries is recalling 4,148 units of Probe Cover Kits used in diagnostic ultrasound procedures due to inadequate barriers at the seams.
Medline is recalling probe cover kits used in cardiac and vascular ultrasound procedures due to inadequate seam barriers. Over 3.7 million units were distributed worldwide from December 2017 through May 2023.
Medline is recalling Probe Cover Kits with sterile Ultrasound Gel because the probe covers may have an inadequate barrier at the seams. These diagnostic ultrasound kits are distributed worldwide.
Medline Probe Cover Kits may have inadequate seam barriers that could allow contamination during diagnostic ultrasound procedures. Approximately 575 units have been distributed worldwide since December 2017.
Medline Industries has recalled 1,505,262 Probe Cover Kits used in diagnostic ultrasound procedures due to an inadequate barrier at the seams. The recall affects units distributed worldwide between December 2017 and May 2023.
Medline is recalling Probe Cover Kits that may have inadequate barrier at the seams, potentially compromising sterility during diagnostic ultrasound procedures. The recall affects kits distributed worldwide from December 2017 through May 2023.