Lin-Zhi International Inc

Complete recall history across all FDA and CPSC categories — 5 total recalls

Lin-Zhi International 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 (5)

FDA medical device enforcement actions by Lin-Zhi International Inc

Date Product Reason Class
Jan 11, 2019 Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l... Shelf life of the product may be reduced due to degradation of the assay. Class III
Feb 18, 2014 Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could n... Class III
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Can... Class II
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Ca... Class II
Oct 3, 2013 Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ... Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a d... Class III

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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