Cardinal Health 200, LLC recalls Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3…
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.
Read the official notice →- Date
- 2025-10-29
- Country
- United States
- Brand
- Cardinal Health
- Product
- Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Cardinal Health recalls
- 2026-03-25
USCardinal Health 200, LLC recalls Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
FDA · DrugCardinal Health 200, LLCNationwide within the United States, Puerto Rico and Japan.Official notice →- 2026-02-04
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Cardinal Health 200, LLC recalls Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal…
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…
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice → - 2025-12-17
- US
Cardinal Health 200, LLC recalls ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T…
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.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2025-09-03
- US
Cardinal Health Inc. recalls Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx…
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
- 2025-08-13
- US
Cardinal Health Inc. recalls RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
- 2025-06-18
- US
Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA · DeviceCardinal Health 200, LLCDomestic US distribution to AK, CA, FL, MA, TX. International distribution to…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-29
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering…
- US
Wipro GE Healthcare Private Ltd. recalls GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical…
Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs…
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Biomet, Inc. recalls BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
FDA · DeviceBiomet, Inc.Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA…Official notice → - US
ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set…
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or…
FDA · DeviceICU Medical, Inc.Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign)…Official notice → - US
Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil,…Official notice → - US
B BRAUN MEDICAL INC recalls Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version:…
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.