The Recall Desk

Manufacturer

Covidien, LLC

341 recalls in our database name Covidien, LLC as the manufacturing or recalling firm.

What the numbers show

Total
341
Critical
4
Severe
111
Most recent
2026-08-26

Of the 341 recalls from Covidien, LLC we have scored against our rubric, 4 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 111 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

176–200 of 341

  • SevereFDA (Devices)·Z-1855-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1859-2016·2016-06-08

    Recall of Vistec X-Ray Detectable Sponges Due to Sterility Breach

    Covidien LLC is recalling Vistec X-Ray Detectable Sponges because a breach of the barrier packaging may have compromised sterility.

    Product
    Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1851-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2016·2016-06-08

    FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach

    The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.

    Product
    Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2016·2016-05-18

    Recall of Given Imaging Bravo pH Capsule Delivery Devices

    Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and chi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2016·2016-05-18

    FDA Recalls Given Imaging Bravo pH Capsule Delivery Device

    FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1219-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1220-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and midstream specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2016·2016-03-30

    Castile Soap Towelettes Recalled for Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and midstream kits due to bacterial contamination.

    Product
    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2016·2016-03-30

    Castile Soap Towelettes in Medical Kits Recalled for Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1205-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2016·2016-03-30

    Aplicare Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling 118,400 kits of Castile soap towelettes due to bacterial contamination. The products are used to clean the genital area.

    Product
    Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1196-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    The FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Covidien

Irish tax-registered company

Country
Ireland
Founded
2007
Parent company
Medtronic plc

Official website

Source: Wikidata (Q908172), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.