Instrumentation Laboratory: Medical Device Recalls in 2026

According to to data from the FDA, there were 21 medical device recalls made by Instrumentation Laboratory in 2026. See the details of the recalls below.

You can see similar recalls for other firms.

• GEM Premier 5000 PAK, Part No. 00055360004.
• GEM Premier 5000; Part No. 00055415005.
• GEM Premier 5000; Part No. 00055445004.
• GEM Premier 5000; Part No. 00055430008.
• GEM Premier 5000; Part No. 00055415010.
• GEM Premier 5000; Model No. 00055430010.
• GEM Premier 5000 PAK; Part No. 00055360011.
• GEM Premier 5000; Part No. 00055415008.
• GEM Premier 5000; Part No. 00055430004.
• GEM Premier 5000 PAK; Part No. 00055360008.
• GEM Premier 5000; Part No. 00055445008.
• GEM Premier 5000 PAK; Part No. 00055407511.
• GEM Premier 5000; Part No. 00055430011.
• GEM Premier 5000 PAK; Part No. 00055415004.
• GEM Premier 5000 PAK; Part No. 00055360010.
• GEM Premier 5000 PAK; Part No. 00055407508.
• GEM Premier 5000; Part No. 00055445010 & 00055445011.
• GEM Premier 5000 PAK; Part No. 00055407510.
• GEM Premier 5000 PAK; Part No. 00055407504.
• GEM Premier 5000; Part No: 00055415011.
• The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.