Caire, Inc.

Complete recall history across all FDA and CPSC categories — 11 total recalls

Caire, 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 (11)

FDA medical device enforcement actions by Caire, Inc.

Date Product Reason Class
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Potential failure of affected units to recharge the battery of the oxygen con... Class II
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Potential failure of affected units to recharge the battery of the oxygen con... Class II
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. Potential failure of affected units to recharge the battery of the oxygen con... Class II
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. Potential failure of affected units to recharge the battery of the oxygen con... Class II
Oct 10, 2022 CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudi... Class I
Oct 10, 2022 CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudi... Class I
Oct 10, 2022 CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudi... Class I
Oct 10, 2022 CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudi... Class I
Mar 25, 2022 CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense... The device was not cleared for U.S. distribution. Class II
Nov 21, 2019 CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeS... Four units of European version FreeStyle Comfort were distributed in the US, ... Class II
Sep 16, 2019 SAROS Oxygen System Model 3000 There is an electronics control issue that causes the unit to not power on wi... 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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