Smiths Medical Asd Inc

Complete recall history across all FDA and CPSC categories — 10 total recalls

Smiths Medical Asd Inc 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 (10)

FDA medical device enforcement actions by Smiths Medical Asd Inc

Date Product Reason Class
Nov 10, 2023 Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 Medex LOGICAL CATH LAB KIT, List Number M20754 There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 6IN PRESSURE TUBING, List Number MX20617 There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
Nov 10, 2023 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R There is a manufacturing defect affecting specific rotator lots. Within this ... Class II
May 4, 2015 Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P... Smiths Medical has become aware of an issue with the Low Volume Extension Set... 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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