RegWardenFDA facility compliance records
Facility

CARDINAL HEALTH P.R. 218, INC.

67 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2016: 4 recalls, 1 inspections; 2017: 4 recalls; 2018: 5 recalls; 2019: 3 recalls; 2020: 9 recalls; 2021: 10 recalls; 2022: 4 recalls; 2023: 8 recalls; 2024: 8 recalls; 2025: 5 recalls; 2026: 4 recalls1’12’131’141’155’164’175’183’199’2010’214’228’238’245’254’26
  • Recalls (67)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

20264 records
  • Class IIOngoing2026-08-10
    The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or o…
  • Class IIOngoing2026-07-29
    The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mil…
  • Class IIOngoing2026-07-14
    Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
  • Class IIOngoing2026-02-27
    The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
20255 records
  • Class IIOngoing2025-12-26
    The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of dev…
  • Class IIOngoing2025-11-12
    Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
  • Class IIOngoing2025-09-18
    Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
  • Class IICompleted2025-05-13
    Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
  • Class IIOngoing2025-05-02
    Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
20248 records
  • Class IIOngoing2024-11-08
    Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
  • Class IIOngoing2024-11-08
    Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
  • Class IIOngoing2024-11-01
    Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
  • Class IOngoing2024-09-25
    Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insuli…
  • Class IIOngoing2024-07-24
    The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
  • Class IIOngoing2024-05-29
    Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical® supplied finished kits. Merit Medical® supplied finished kits are included as components in Presource kit…
  • Class IIOngoing2024-04-17
    Potential contamination of the product with latex adhesive residual.
  • Class IIOngoing2024-03-27
    Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
20238 records
  • Class IOngoing2023-12-28
    Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connect…
  • Class IICompleted2023-12-21
    The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
  • Class IOngoing2023-12-04
    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
  • Class IOngoing2023-09-20
    Demonstrated recognition and compatibility issues with syringe infusion pumps.
  • Class IIOngoing2023-09-13
    Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
  • Class IIOngoing2023-08-16
    Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
  • Class IIOngoing2023-06-16
    Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
  • Class IIOngoing2023-04-06
    Inadvertently released for distibution without sterility assurance.
20224 records
  • Class IIOngoing2022-12-14
    Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken…
  • Class IIOngoing2022-11-18
    Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity
  • Class IIOngoing2022-09-28
    Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates .
  • Class IICompleted2022-03-15
    Product was distributed without being sterilized.
202110 records
  • Class IIOngoing2021-11-02
    Potential for open packaging seals compromising the sterility of the surgical gowns
  • Class ITerminated2021-06-16
    The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a …
  • Class IITerminated2021-06-09
    A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the li…
  • Class IITerminated2021-05-21
    The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations.
  • Class IITerminated2021-02-25
    Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
  • Class IITerminated2021-02-11
    Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource® kit SANHDJTVCF Judkins Pack lot # 525067.
  • Class IITerminated2021-02-09
    Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
  • Class IICompleted2021-01-19
    The potential for air appearing in the enteral feed pumping set tubing during set-up.
  • Class IIOngoing2021-01-07
    There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
  • Class IITerminated2021-01-07
    Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
20209 records
  • Class IITerminated2020-09-25
    Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/p…
  • Class IIOngoing2020-09-22
    The feeding spike sets may leak at the interface of the tube and spike connector.
  • Class IITerminated2020-07-30
    Only providing one nasal swab in our pre-operative kit instead of the 4 required for proper treatment.
  • Class IICompleted2020-07-29
    A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
  • Class IITerminated2020-06-04
    Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
  • Class IITerminated2020-01-31
    The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and inc…
  • Class IITerminated2020-01-31
    The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and …
  • Class IITerminated2020-01-15
    Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any repo…
  • Class IITerminated2020-01-11
    The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
20193 records
  • Class IITerminated2019-10-28
    The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers). The measurement readings drift upwards …
  • Class IICompleted2019-04-30
    Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
  • Class IITerminated2019-03-22
    Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
20185 records
  • Class IITerminated2018-12-27
    Curity All Purpose Sponges were not sterilized and distributed
  • Class IITerminated2018-10-31
    Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to t…
  • Class IITerminated2018-06-11
    The suction valve may not close properly which could cause continuous suction.
  • Class IITerminated2018-03-28
    products may be missing a one-way valve on the fluid patient port.
  • Class IITerminated2018-02-20
    A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
20174 records
  • Class IITerminated2017-08-01
    The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1® inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
  • Class IITerminated2017-07-28
    Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings.
  • Class IITerminated2017-06-27
    Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
  • Class IITerminated2017-04-21
    Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.
20164 records
  • Class IITerminated2016-09-23
    Potential risk associated with corrosion demonstrated on the distraction screw surface.
  • Class IITerminated2016-07-20
    Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum v…
  • Class IITerminated2016-06-27
    Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.
  • Class IITerminated2016-02-29
    Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
20151 record
  • Class IITerminated2015-08-25
    Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
20141 record
  • Class IITerminated2014-12-23
    A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
20121 record
  • Class IITerminated2012-12-18
    Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

FDA inspections (1)

  • VAI2016-11-16
    Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CARDINAL HEALTH P.R. 218, INC. (FEI 3003370911) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003370911-cardinal-health-p-r-218-inc/

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