Instrumentation Laboratory recalls

Instrumentation Laboratory has 77 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 12 Aug 2026. 46 are still ongoing. 30 were reported in the last 12 months.

Total recalls77since 2012

Last 12 months30reported

Class I00% of total

Ongoing46latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 1Feb 0 0 0May 0 0 1Aug 0 0 0Nov 1 1 0Feb 20 0 0May 0 0 8Aug 0 0

Severity split

Class I 0 0%Class II 76 99%Class III 1 1%

Why instrumentation laboratory is recalled

Product types

By year

20262938%
202534%
2023810%
202223%
202145%
201934%
201823%
201611%
2014810%
20131114%

Ongoing instrumentation laboratory recalls

46 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	The GEM Premier 7000 with iQM3 is a portable critical care recalled	Instrumentation Laboratory	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory	Instrumentation Laboratory	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide

All instrumentation laboratory recalls, newest first

77 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	The GEM Premier 7000 with iQM3 is a portable critical care recalled	Instrumentation Laboratory	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory	Instrumentation Laboratory	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
18 Mar 2026Device	CLASS II	GEM Premier 5000 PAK recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
21 Jan 2026Device	CLASS II	The product is used for the evaluation of the intrinsic recalled	Instrumentation Laboratory	Sterility	Nationwide
24 Dec 2025Device	CLASS III	HemosIL SynthAFax recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	8 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.