Centurion CIT6750A

• • Ongoing Z-3267-2026 FDA Class II ·initiated 10 Aug 2026

  The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

• • Ongoing Z-3229-2026 FDA Class II ·initiated 10 Aug 2026

  Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

• • Ongoing Z-3209-2026 FDA Class II ·initiated 31 Jul 2026

  Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

• • Ongoing Z-3137-2026 FDA Class II ·initiated 23 Jul 2026

  The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.

• • Ongoing Z-3070-2026 FDA Class II ·initiated 20 Jul 2026

  Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.

• • Ongoing Z-3024-2026 FDA Class II ·initiated 10 Jul 2026

  Kits contain a potentially contaminated component which were recalled by the manufacturer

• • Ongoing Z-2995-2026 FDA Class II ·initiated 8 Jul 2026

  Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.

• • Ongoing Z-3054-2026 FDA Class II ·initiated 12 Jun 2026

  The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

• • Ongoing Z-2736-2026 FDA Class II ·initiated 10 Jun 2026

  Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.

• • Ongoing Z-2764-2026 FDA Class I ·initiated 8 Jun 2026

  The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.

• 3 recalls, same reason

  • Ongoing Z-2747-2026 FDA Class I ·initiated 5 Jun 2026
  • Ongoing Z-2748-2026 FDA Class I ·initiated 5 Jun 2026 ·via K213481, on the same 510(k)
  • Ongoing Z-2749-2026 FDA Class I ·initiated 5 Jun 2026 ·via K213481, on the same 510(k)

  Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.

• • Ongoing Z-2611-2026 FDA Class II ·initiated 28 May 2026

  Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

• • Ongoing Z-2697-2026 FDA Class II ·initiated 28 May 2026

  Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.

• • Ongoing Z-2541-2026 FDA Class II ·initiated 21 May 2026

  The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

• • Ongoing Z-2497-2026 FDA Class II ·initiated 4 May 2026

  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

• 3 recalls, same reason

  • Ongoing Z-2441-2026 FDA Class II ·initiated 27 Apr 2026
  • Ongoing Z-2440-2026 FDA Class II ·initiated 27 Apr 2026
  • Ongoing Z-2439-2026 FDA Class II ·initiated 27 Apr 2026

  Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

• • Ongoing Z-2236-2026 FDA Class I ·initiated 10 Apr 2026

  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

• • Ongoing Z-1824-2026 FDA Class II ·initiated 16 Mar 2026

  On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.

• • Ongoing Z-2041-2026 FDA Class II ·initiated 16 Mar 2026

  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

• • Ongoing Z-1890-2026 FDA Class II ·initiated 27 Feb 2026

  Unapproved design changes to the products outside of the 510(k) clearance.

• • Ongoing Z-2590-2026 FDA Class II ·initiated 27 Feb 2026

  Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

• • Ongoing Z-1710-2026 FDA Class II ·initiated 16 Feb 2026

  Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

• • Ongoing Z-1466-2026 FDA Class II ·initiated 8 Jan 2026

  Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.

• • Ongoing Z-2101-2026 FDA Class II ·initiated 7 Jan 2026

  Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

• • Ongoing Z-1330-2026 FDA Class II ·initiated 24 Dec 2025

  Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

• • Ongoing Z-0448-2026 FDA Class I ·initiated 10 Oct 2025

  Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

• • Ongoing Z-0137-2026 FDA Class II ·initiated 10 Sep 2025

  Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

• • Ongoing Z-2592-2025 FDA Class I ·initiated 8 Aug 2025

  Convenience kits labeled as sterile have not gone through the sterilization process.

• • Ongoing Z-2452-2025 FDA Class II ·initiated 8 Jul 2025

  Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

• 2 recalls, same reason

  • Ongoing Z-1810-2025 FDA Class I ·initiated 22 Apr 2025 ·via K213481, on the same 510(k)
  • Ongoing Z-1809-2025 FDA Class I ·initiated 22 Apr 2025

  Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

• • Ongoing Z-1505-2025 FDA Class I ·initiated 24 Feb 2025

  Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

• • Ongoing Z-1368-2025 FDA Class II ·initiated 13 Feb 2025

  Potential breach in pouch packaging which could lead to loss of sterility.

• • Ongoing Z-1183-2025 FDA Class II ·initiated 9 Jan 2025

  Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

• • Ongoing Z-0991-2025 FDA Class I ·initiated 31 Dec 2024

  The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

• • Ongoing Z-1049-2025 FDA Class II ·initiated 23 Dec 2024

  Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

• • Ongoing Z-0788-2025 FDA Class II ·initiated 21 Nov 2024

  Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

• • Ongoing Z-1040-2025 FDA Class II ·initiated 18 Nov 2024

  Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

• • Ongoing Z-0119-2025 FDA Class II ·initiated 28 Aug 2024

  Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

• 4 recalls, same reason

  • Ongoing Z-2631-2024 FDA Class II ·initiated 8 Apr 2024
  • Ongoing Z-2767-2024 FDA Class II ·initiated 8 Apr 2024
  • Ongoing Z-2775-2024 FDA Class II ·initiated 8 Apr 2024
  • Ongoing Z-2515-2024 FDA Class II ·initiated 8 Apr 2024

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Centurion

Generic Name

Circumcision kit, single-use

Model / Ref / Catalog

CIT6750A

Primary DI / UDI-DI

10653160395232

510(k) Number

K213481 ↗

FDA Product Code

LRO

GMDN Term

Circumcision kit, single-use

Device Class

Class II

Regulation Number

878.4370

Commercial Distribution

In Commercial Distribution

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