PlainRecalls

Covidien LLC

226 recalls on record · Latest: Mar 18, 2026

Covidien LLC Recall Insight

Covidien LLC appears on 226 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.269% 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 1 critical, 49 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 47 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 May 2, 2018 to Feb 26, 2020.

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 Feb 26, 2020

Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation a…

FDA Devices Moderate Feb 26, 2020

Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation a…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligatio…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation a…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or li…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation an…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation a…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or lig…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation a…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation …

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation …

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and…

FDA Devices Moderate Feb 26, 2020

Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and o…

FDA Devices Moderate Jul 17, 2019

MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005…

FDA Devices Moderate Jun 26, 2019

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT

FDA Devices Moderate Jun 26, 2019

EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT

FDA Devices Moderate Jun 26, 2019

EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT

FDA Devices Moderate Jun 26, 2019

EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

FDA Devices Moderate Jun 26, 2019

EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

FDA Devices Moderate Jun 26, 2019

SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

FDA Devices Moderate May 1, 2019

Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotatin…

FDA Devices Moderate May 1, 2019

Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a varie…

FDA Devices Moderate May 1, 2019

Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECI…

FDA Devices Moderate Apr 3, 2019

Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperativ…

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraope…

FDA Devices Moderate Dec 26, 2018

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraop…

FDA Devices Moderate Dec 26, 2018

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

FDA Devices Critical Dec 26, 2018

Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan …

FDA Devices Moderate Nov 21, 2018

Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape,…

FDA Devices Moderate Oct 10, 2018

Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing f…

FDA Devices Moderate Oct 10, 2018

Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for banda…

FDA Devices Moderate Oct 10, 2018

Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dres…

FDA Devices Moderate Oct 10, 2018

Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for b…

FDA Devices Moderate Oct 10, 2018

Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing contai…

FDA Devices Moderate Oct 10, 2018

Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing f…

FDA Devices Moderate Sep 26, 2018

P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS

FDA Devices Moderate Sep 26, 2018

400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD

FDA Devices Moderate Sep 26, 2018

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD

FDA Devices Moderate Sep 5, 2018

Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 108845211303…

FDA Devices Moderate Aug 8, 2018

Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955

FDA Devices Moderate May 2, 2018

EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 2…

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Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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