Fresenius Medical Care Holdings, Inc. recalls Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX…
To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the…
Read the official notice →- Date
- 2025-10-15
- Country
- United States
- Brand
- Fresenius Medical Care Holdings
- Product
- Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Fresenius Medical Care Holdings recalls
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USFresenius Medical Care Holdings, Inc. recalls Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the…
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NY, TN and TX.Official notice →- 2026-05-13
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Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- 2025-12-24
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Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
- 2025-07-02
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- 2025-06-25
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Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the state of Massachusetts.Official notice → - 2025-01-15
- US
Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
Potential for internal blood leaks due to cracked polyurethane
Other drugs & medical recalls in the United States
- 2025-10-15
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
FDA · DeviceAbiomed, Inc.Nationwide distribution. International distribution to United Arab Emirates,…Official notice → - US
GE Medical Systems, SCS recalls AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
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FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated…
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CORNEAT VISION, LTD. recalls CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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ImaCor Inc. recalls ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
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Canon Medical System, USA, INC. recalls This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The…
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the…