FDA (Devices) recall action 65205
The FDA (Devices) publishes a recall like this one as 22 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 22 pages.
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
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.
Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.
Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.
Surgical Instrument Service And Savings, Inc. is recalling four units of TPS Micro Reciprocating Small Tear Cross Cut Rasps because the sterile barrier seal may be compromised.
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.
Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasps because the sterile seal may be compromised, allowing the product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially allowing product to fall out of the pouch.
Surgical Instrument Service and Savings, Inc. is recalling 259 ENDOPATH trocars and accessories because compromised sterile seals may allow product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 10 orthopedic drill bits because the sterile barrier seal was compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 15 suture instruments because compromised seals may allow the sterile barrier to fail.
Surgical Instrument Service And Savings, Inc. is recalling 907 arthroscopic instruments because compromised sterile seals may allow product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling two lots of IDEAL Suture Graspers because the sterile barrier seal may be compromised, allowing the product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 229 units of compression sleeves and garments because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 13 medical devices because compromised seals may allow products to fall out of sterile pouches.
Surgical Instrument Service And Savings, Inc. is recalling Harmonic ACE Curved Shears because the sterile seal may be compromised, allowing the product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.
Surgical Instrument Service And Savings, Inc. is recalling 73 arthroscopic cannulas because a compromised seal may allow the product to fall out of the sterile pouch.
Surgical Instrument Service And Savings, Inc. is recalling 30 surgical instrument motors and accessories because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.