Symbios Medical Products, LLC

Complete recall history across all FDA and CPSC categories — 12 total recalls

Symbios Medical Products, LLC 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 (12)

FDA medical device enforcement actions by Symbios Medical Products, LLC

Date Product Reason Class
May 10, 2013 Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr )... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOL... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL sid... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,..... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(15... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/si... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2m... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml pe... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
May 10, 2013 Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary re... Class I
Feb 25, 2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... Received 2 complaints out of 458 distributed pumps in this lot, where flow re... Class I

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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