Recall Atlas
Drugs & medicalClass I

Glycar SA Pty., Ltd. recalls SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

The impacted lot may not meet the required tensile strength specification.

Read the official notice →
Date
2025-12-03
Country
United States
Brand
Glycar SA Pty., Ltd.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Classification
Class I
Units
US
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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.

Other drugs & medical recalls in the United States

  1. 2025-12-03
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product…

    Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Foundation Medicine, Inc. recalls FoundationOne CDx (F1CDx), RAL-0003 version 31.0

    Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

    FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution to states of: AL, AZ, CA, FL, GA, IL, IN, KS, KY,…Official notice →
  4. US
    Drugs & medicalClass I

    Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…

    Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

    FDA · DeviceOlympus Corporation of the AmericasUS-wide distributionOfficial notice →
  5. US
    Drugs & medicalClass II

    CA BOTANA International, Inc. recalls Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC,…

    CGMP Deviations

    FDA · DrugCA BOTANA International, Inc.CA, CO, FL, PR, WAOfficial notice →
  6. US
    Drugs & medicalClass I

    Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use),…

    Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

    FDA · DrugFresenius Kabi USA, LLCNationwide within the United States as well as AK, HI, and PR.Official notice →
  7. US
    Drugs & medicalClass II

    Medical Products Laboratories, Inc. recalls Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL…

    Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis

    FDA · DrugMedical Products Laboratories, Inc.Nationwide USAOfficial notice →
See all drugs & medical recalls →