ICU Medical de Mexico, S.A. de C.V.

Complete recall history across all FDA and CPSC categories — 20 total recalls

ICU Medical de Mexico, S.A. de C.V. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (20)

FDA medical device enforcement actions by ICU Medical de Mexico, S.A. de C.V.

Date Product Reason Class
Mar 1, 2018 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotatin... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Cl... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check ... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Ch... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, ... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cle... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotati... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to i... Class II
Mar 1, 2018 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave ... ICU Medical is expanding the scope of their previously initiated recall to in... Class II
Mar 1, 2018 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to in... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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