BEUDAMED
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    Filters FDA Recall × Status: Open, Classified × Clear all

    Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

    FDA Recall
    Open, Classified ·Church & Dwight Inc·Product code LCX·January 25, 2023

    Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code GCX·December 26, 2025

    Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    Medline EBSI Kit EBSI1534

    FDA Recall
    Open, Classified ·Product code LRP·April 27, 2026

    DORO Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

    FDA Recall
    Open, Classified ·Pro-Med Instruments Gmbh BOETZINGER STRASSE 86 Freiburg Im Breisgau Germany·Product code HBL·March 14, 2025

    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDJ·January 7, 2022

    Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system

    FDA Recall
    Open, Classified ·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025

    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.

    FDA Recall
    Open, Classified ·SenTec AG Ringstrasse 39 Therwil Switzerland·Product code LKD·August 22, 2022

    Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

    FDA Recall
    Open, Classified ·Medica Corporation·Product code CEM·December 31, 2025

    Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837

    FDA Recall
    Open, Classified ·Product code OXQ·April 27, 2026

    Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mechanism. Available with or without a titanium pyramid. The lanyard is part of the Alpha Interlock" Suspension System. This system allows you to interchange suspension methods without remaking a socket Model, 3 part numbers - 700-AIS100, Alpha Interlock Suspension System with Alpha Lanyard - 700-AIS101, Alpha Interlock Suspension System with Alpha Lanyard w/Titanium Pyramid - 700-AIS107, Alpha Interlock Suspension System Lanyard Body ONLY

    FDA Recall
    Open, Classified ·WillowWood Global Llc·Product code IPM·April 20, 2021

    Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.

    FDA Recall
    Open, Classified ·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·January 22, 2024

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A

    FDA Recall
    Open, Classified ·HF Acquisition Co LLC·Product code FRC·April 13, 2026

    Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH; g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580; h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H; i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A; j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081; k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080; l) PORT ACCESS PACK-LF, REF DYNJ0352159D; m) PORT DRESSING CHANGE KIT, REF DT22810; n) PORT DRESSING CHANGE TRAY, REF DT20640B; o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A; p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH; q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528; r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H; s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937; t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A; u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH; v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161; w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530; x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489; y) CENTRAL LINE DRESSING KIT, REF EBSI1088A; z) CENTRAL LINE DRESSING KIT, REF EBSI1088B; aa) CENTRAL LINE KIT, REF EBSI1245B; bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B; cc) CVC DRESSING CHANGE KIT, REF EBSI1472A; dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C; ee) CVL DRESSING CHANGE KIT, REF EBSI1547; ff) DIALYSIS CHANGE KIT, REF EBSI1453; gg) DIALYSIS KIT, REF EBSI1476; hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A; ii) DRESSING CHANGE TRAY, REF EBSI1513; jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B; kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A; ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A; mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524; oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555; pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135; qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A; rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087; ss) PICC DRESSING CHANGE KIT, REF EBSI1471A; tt) PICC DRESSING CHANGE TRAY, REF EBSI1512; uu) PICC DRESSING CHANGE TRAY, REF EBSI1546; vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486; ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523; xx) PORT ACCESS TRAY, REF DYNDC2703A; yy) PORT DRESSING CHANGE KIT, REF EBSI1434A; zz) PORT DRESSING CHANGE KIT, REF EBSI1525; aaa) PORT DRESSING CHANGE KIT, REF EBSI1525; bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A; ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OXQ·November 15, 2023