FDA (Devices) recall action 90989
The FDA (Devices) publishes a recall like this one as 18 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 18 pages.
During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.
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.
3M is recalling 84,000 units of Steri-Drape surgical drapes because the adhesive component's liner is difficult to remove without damaging the product, and there have been reported adhesive-related skin injuries.
3M is recalling surgical drapes with defective adhesive components that may cause skin injuries. The adhesive liner is difficult to remove without damaging the product, and increased skin injuries have been reported.
3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is difficult to remove without damaging the product.
3M recalls specific batches of Steri-Drape surgical drapes due to reported adhesive-related skin injuries and potential product damage from difficult-to-remove adhesive liners.
3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.
3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.
3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.
3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.
3M is recalling Steri-Drape surgical drapes because the liner on the adhesive component is difficult to remove without damaging the drape. An increase in adhesive-related skin injuries has been reported for affected lots.
3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.
3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.
3M is recalling 769,810 Steri-Drape surgical drapes worldwide due to a defective adhesive liner that is difficult to remove and has caused reported skin injuries.
3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.
3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in skin injuries.
3M is recalling Steri-Drape Large Towel Drapes (REF 1010NS) due to adhesive liner defects that may damage the product and increased reports of adhesive-related skin injuries from affected lots.
3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.
3M is recalling Steri-Drape surgical drapes due to a defective adhesive liner that is difficult to remove and may render the drape unusable. Reported adhesive-related skin injuries have been linked to the affected lots.
3M is recalling 554,200 surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and render it unusable. The company has received reports of adhesive-related skin injuries from the affected lots.