is it on recall

Home / Brand archive

Covidien Llc recall records

24 reported ongoing

41 records in this archive. Latest source date May 13, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 1088452...

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, O...

Official source
FDA device enforcement

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Numb...

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, M...

Official source
FDA device enforcement

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway managem...

Due to customer complaint regarding incorrect display box labeling.

Class IIReported ongoing

Distribution: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.

Official source
FDA device enforcement

HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vi...

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.

Official source
FDA device enforcement

EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only

Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA,...

Official source
FDA device enforcement

Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM

Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary interv...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.

Official source
FDA device enforcement

Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source
FDA device enforcement

Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Class IReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ...

Official source

Reasons in these listed records

  • The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
  • Temperature probe devices lack FDA clearance.
  • Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
  • Due to customer complaint regarding incorrect display box labeling.

These examples come from this result page and are not a ranking of every recall reason.

Checking Covidien Llc

Is there a recall on covidien llc right now?

This archive contains 41 records, including 24 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking

Search Covidien LlcBrowse related productsReview source dates