PlainRecalls

Covidien LLC

Compiled from official public sources by the editorial team.

335 recalls on record · Latest: Mar 18, 2026

Covidien LLC Recall Insight

Covidien LLC appears on 335 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.329% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Jul 29, 2015 to Mar 30, 2016.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Mar 30, 2016

Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG …

FDA Devices Moderate Mar 30, 2016

Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patien…

FDA Devices Moderate Mar 30, 2016

Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female patien…

FDA Devices Moderate Mar 30, 2016

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 p…

FDA Devices Moderate Mar 30, 2016

Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female pati…

FDA Devices Moderate Mar 30, 2016

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 pat…

FDA Devices Moderate Mar 30, 2016

Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and femal…

FDA Devices Moderate Mar 30, 2016

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 patie…

FDA Devices Moderate Mar 30, 2016

Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients

FDA Devices Moderate Mar 30, 2016

Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female p…

FDA Devices Moderate Mar 30, 2016

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2090SA Castile soap towelettes are used to clean the genital area for male and female patien…

FDA Devices Moderate Mar 30, 2016

Covidien Dover MIDSTREAM KIT CASTILE SOAP Item Code: 2040SA Castile soap towelettes are used to clean the genital area for male and female patien…

FDA Devices Moderate Mar 9, 2016

Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 4614…

FDA Devices Moderate Mar 9, 2016

Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Inte…

FDA Devices Moderate Dec 2, 2015

Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is…

FDA Devices Moderate Dec 2, 2015

Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic…

FDA Devices Moderate Dec 2, 2015

Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145…

FDA Devices Moderate Dec 2, 2015

Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Palindrom…

FDA Devices Moderate Dec 2, 2015

Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrom…

FDA Devices Moderate Sep 9, 2015

Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible…

FDA Devices Moderate Sep 9, 2015

MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC

FDA Devices Moderate Sep 9, 2015

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Ster…

FDA Devices Moderate Sep 9, 2015

Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage:…

FDA Devices Moderate Sep 9, 2015

Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usag…

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 …

FDA Devices Moderate Sep 9, 2015

MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: …

FDA Devices Moderate Sep 9, 2015

MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usa…

FDA Devices Moderate Sep 9, 2015

MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage…

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: …

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Us…

FDA Devices Moderate Sep 9, 2015

Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage…

FDA Devices Moderate Sep 9, 2015

Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage:…

FDA Devices Moderate Sep 9, 2015

Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Produ…

FDA Devices Moderate Sep 2, 2015

Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infa…

FDA Devices Moderate Sep 2, 2015

Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infant…

FDA Devices Moderate Jul 29, 2015

ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI U…

FDA Devices Moderate Jul 29, 2015

Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CP…

FDA Devices Moderate Jul 29, 2015

Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/…

FDA Devices Moderate Jul 29, 2015

Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY …

FDA Devices Moderate Jul 29, 2015

Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Doubl…

FDA Devices Moderate Jul 29, 2015

Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor K…

FDA Devices Moderate Jul 29, 2015

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

FDA Devices Moderate Jul 29, 2015

Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT

FDA Devices Moderate Jul 29, 2015

Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK

FDA Devices Moderate Jul 29, 2015

Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Ki…

FDA Devices Moderate Jul 29, 2015

Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC …

FDA Devices Moderate Jul 29, 2015

Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-O…

FDA Devices Moderate Jul 29, 2015

NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.