Welch Allyn, Inc/Mortara

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

Welch Allyn, Inc/Mortara 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 Welch Allyn, Inc/Mortara

Date Product Reason Class
Nov 11, 2020 ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance... The radio within the device can become disassociated with the wireless access... Class II
Mar 18, 2020 H12+ and patient cable for the H12+ Holter Recorders with the following devic... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 S4 and patient cable for the S4 Wireless Telemeter with the following device ... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 ELI PC. The ELI PC Service automatically converts resting ECG recordings coll... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real ... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabil... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 T12. Incorporates wireless electrocardiographic technology to achieve the rea... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the ... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 Lead diagnostic electrocardiograph under the following device names: ELI 10, ... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... Class II
Mar 18, 2020 X12+ and patient cable for the X12+ Telemeter with the following device name:... Impacted Welch Allyn products may not meet the Defibrillation Withstand req... 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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