Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Complete recall history across all FDA and CPSC categories — 7 total recalls

Covidien LP (formerly Nellcor Puritan Bennett 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 (7)

FDA medical device enforcement actions by Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Date Product Reason Class
Jan 15, 2016 Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... Graphical user interface (GUI) unresponsive to touch and Loss of primary vent... Class II
Jul 16, 2015 Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... Reports in which tidal volumes reaching patients were lower than set tidal vo... Class I
Jun 29, 2015 OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For c... Potential missing segments on the display that can result in misinterpretatio... Class II
Jun 29, 2015 OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of func... Potential missing segments on the display that can result in misinterpretatio... Class II
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... Reports where patients who recently switched from the current Shiley Neonatal... Class I
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... Reports where patients who recently switched from the current Shiley Neonatal... Class I
Jan 12, 2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... Covidien is issuing a voluntary field action for all Puritan Bennett 980 vent... 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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