The Recall Desk

Manufacturer

Cardinal Health 200, LLC

297 recalls in our database name Cardinal Health 200, LLC as the manufacturing or recalling firm.

What the numbers show

Total
297
Critical
5
Severe
27
Most recent
2026-09-09

Of the 297 recalls from Cardinal Health 200, LLC we have scored against our rubric, 5 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (9%) are Severe.

Which agencies issued them

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.

151–175 of 297

  • HighFDA (Devices)·Z-0972-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0969-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drain: Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Contraindicated for Infants and Neonates

    Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0191-2023·2022-11-16

    Cardinal Health insulated gel pack recalled for infant contraindication

    Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Reusable Medium Contraindicated for Infant Use

    Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Restricted for Infants

    Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.

    Product
    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2023·2022-11-16

    Cardinal Health Insulated Gel Pack Recalled for Infant Safety

    Cardinal Health is recalling its insulated gel pack because it should not be used on infants or neonates. The product labeling will be updated with a caution statement.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2023·2022-11-16

    Reusable gel pack recalled due to infant use contraindication

    Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.

    Product
    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0188-2023·2022-11-16

    Cardinal Health Insulated Gel Pack recalled; not safe for infants

    Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.

    Product
    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2023·2022-11-16

    Cardinal Health Reusable Gel Pack Recalled for Unsafe Infant Use

    Cardinal Health Reusable Gel Packs are being recalled because they are unsafe for use on infants or neonates. The company will add a warning label stating the product is not for use on infants.

    Product
    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2022·2022-04-20

    Cardinal Health Surgical Gloves Recalled for Lack of Sterilization

    Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.

    Product
    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2244-2021·2021-08-25

    Argyle UVC Insertion Tray Recalled for Safety Scalpel Locking Defect

    Cardinal Health's Argyle UVC Insertion Tray, used for neonatal umbilical catheter insertion, lacks proper instructions for the included Safety Scalpel N11. Once locked, clinicians cannot unlock it, potentially delaying critical treatment.

    Product
    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2021·2021-07-28

    Infant Heel Warmer Recalled Due to Risk of Rupture and Contents Splashing

    Cardinal Health is recalling 2.9 million infant heel warmers that may rupture or leak during activation, potentially splashing heated contents onto infants' eyes or skin and causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2021·2021-07-28

    Infant Heel Warmer Units Recalled for Rupture and Chemical Splashing Risk

    Cardinal Health is recalling 926,425 infant heel warmers (SKU MH00002T) due to reports of pack rupture or leaking during activation. The heated liquid may splash into a user's eyes or onto an infant, potentially causing rash, burn, or inflammation.

    Product
    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2021·2021-07-14

    Nonsterile Radial/Femoral Angiography Drapes Recalled for Sticking Defect

    Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.

    Product
    Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2021·2021-07-14

    Sterile Femoral Angiography Drape Recall Due to Sticking Plastic Film

    Cardinal Health is recalling sterile femoral angiography drapes because the plastic film causes drapes to stick, which may prevent proper unfolding and application during procedures.

    Product
    Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2021·2021-07-14

    Cesarean Birth Drapes Recalled Due to Sticking Plastic Film

    Cardinal Health is recalling 1,638 units of Sterile Cesarean Birth Drapes due to defective plastic film that prevents proper unfolding and application during surgery.

    Product
    Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2021·2021-07-14

    Sterile Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 3,192 units of Sterile Radial/Femoral Angiography Drapes due to sticking plastic film that may prevent proper unfolding and application during surgical procedures.

    Product
    Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2021·2021-07-14

    Angiography and Cesarean Birth Drapes recalled due to sticking defect

    Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.

    Product
    Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2021·2021-07-14

    Cesarean Birth Drapes recalled due to defective plastic film causing sticking

    Cardinal Health is recalling Cesarean Birth Drapes due to a plastic film defect. The defect causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2021·2021-07-14

    Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.

    Product
    Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2031-2021·2021-07-14

    Sterile Femoral Angiography Drape Sticks; Cannot Unfold Properly

    Cardinal Health is recalling 574 units of Sterile Femoral Angiography Drapes because the plastic film causes the drapes to stick, preventing proper unfolding and application during surgery.

    Product
    Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide