Westmed, Inc.

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

Westmed, 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 Westmed, Inc.

Date Product Reason Class
Sep 27, 2024 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5... Due to connector within the circuit flex extender not meeting specifications ... Class II
Nov 11, 2020 Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX ... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Nov 11, 2020 REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Fem... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Nov 11, 2020 REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Nov 11, 2020 REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 1... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Nov 11, 2020 REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect w... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Nov 11, 2020 REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigta... There is a potential that the fitment between the oxygen delivery tube and th... Class II
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for... A repair was made to an adapter mold resulting in parts being produced with c... Class II
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible I... A repair was made to an adapter mold resulting in parts being produced with c... Class II
Jan 15, 2019 Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for u... A repair was made to an adapter mold resulting in parts being produced with c... 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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