Covidien
Complete recall history across all FDA and CPSC categories — 21 total recalls
Covidien 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 (21)
FDA medical device enforcement actions by Covidien
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 23, 2025 | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 1000594... | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting... | Class II |
| May 21, 2025 | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT... | Ventilator Printed Circuit Board Assembly may have two separate capacitors th... | Class I |
| Feb 26, 2025 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C... | Tracheostomy tube with cuff reusable inner cannula has a flange that may disc... | Class I |
| Jul 9, 2024 | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the d... | Class I |
| Jul 9, 2024 | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Class II |
| Jul 9, 2024 | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only | Battery management system within Laryngoscope devices may deplete below the d... | Class I |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled ... | Class I |
| Feb 21, 2024 | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blu... | Class II |
| Jan 9, 2024 | Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC | manufacturing defects to sensor cable connectors may result in error codes ... | Class II |
| Jan 9, 2024 | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC | manufacturing defects to sensor cable connectors may result in error codes ... | Class II |
| Nov 16, 2023 | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10G... | Due to software issue, New systems may exhibit an error which may prohibit us... | Class II |
| Sep 28, 2023 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Defective video laryngoscopes that did not pass quality tests established for... | Class I |
| Aug 22, 2023 | Puritan Bennett Cuff Pressure Manager, REF: 180-03 | Inadequate internal fixation of the power inlet port to the cuff pressure man... | Class II |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent ... | Class II |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent ... | Class II |
| Mar 24, 2023 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: ... | A manufacturing error, resulted in a less than specified diameter of adult fl... | Class I |
| Feb 10, 2023 | COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. ... | Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inf... | Class II |
| Mar 5, 2021 | Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cuttin... | Investigations related to customer complaints received for particulate matter... | Class II |
| Dec 10, 2014 | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... | A manufacturing error resulted in the risk of incorrect proximal and distal b... | Class I |
| Dec 10, 2014 | Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, ... | A manufacturing error resulted in the risk of incorrect proximal and distal b... | Class I |
| Dec 16, 2013 | Puritan Bennett 840 ventilator systems software part number 4-070212-85, revi... | Covidien is conducting a voluntary field corrective action on Puritan Bennett... | 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.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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