Recall archive
64 recalls · page 3 of 3
Reported Mar 30, 2016
Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
33 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 9, 2016
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 2, 2015
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Incorrectly packaged with a 90 degree bend at the distal tip
4 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2015
Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Sterility may be compromised
15 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2015
Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2015
Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Devon Light Gloves contain splits or holes compromising the sterility
13 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2015
Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Catheters may not meet antimicrobial specification
61 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2015
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
FDA (openFDA device enforcement)
Reported Dec 17, 2014
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nellcor Puritan Bennett Inc. (dba Covidien LP)
Matched: Brand · Product · Product details · Reason for recall — Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing…
FDA (openFDA device enforcement)
Reported Oct 22, 2014
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Covidien LLC
Matched: Brand · Product · Product details · Reason for recall — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Straps may separate from the foam pad.
FDA (openFDA device enforcement)
Reported Sep 18, 2013
Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2013
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Covidien LLC
Matched: Brand · Reason for recall — On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 8, 2013
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand — Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 19, 2012
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC dba Uni-Patch
Matched: Brand · Reason for recall — Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 26, 2012
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Brand · Product · Product details — Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
FDA (openFDA device enforcement)
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