341 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
FDA Recall
Open, Classified
·Young Dental Mfg Co I LLC·Product code JOJ·December 29, 2021
Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207
FDA Recall
Terminated
·Hollister Stier Laboratories LLC·Product code LDH·April 20, 2006
Viscot Medical, LLC., Vismark Gentian Violet Marking Pad, Rx Only, Sterile, REF GV1200S. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
FDA Recall
Terminated
·Halyard Health·Product code BSY·January 16, 2015
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
FDA Recall
Terminated
·Halyard Health·Product code BSY·January 16, 2015
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences Llc·Product code DTL·October 19, 2010
Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
FDA Recall
Terminated
·Edwards Lifesciences Llc·Product code DTL·October 19, 2010
KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
FDA Recall
Terminated
·Halyard Health·Product code BSY·January 16, 2015
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
FDA Recall
Open, Classified
·DJO, LLC·Product code JOW·January 17, 2019
Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
FDA Recall
Terminated
·Riverpoint Medical, LLC·Product code IWJ·February 8, 2019
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
FDA Recall
Open, Classified
·ASO, LLC·Product code NAB·October 16, 2018
Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596. Intended use: Kit components to be used during Intermittent Urinary Catheterizations.
FDA Recall
Terminated
·Apogee Medical·Product code KMJ·January 18, 2011
Sterilized gowns and towels. MULTI-GOWN PACK: MAJOR - contains 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' re-usable wrappers, 1 24'' re-usable wrappers Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***.
FDA Recall
Terminated
·Sterile Surgical Systems Llc·Product code FYA·June 4, 2002
Sterilized gowns and towels. MULTI-GOWN PACK: MINOR - contains - 2 operating room towels, 1 each extra large double-ply scrub nurse gown/towel, 1 each extra large gortex surgeons gown/towel, 2 30'' re-usable wrappers, 1 24'' re-usable wrappers Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***.
FDA Recall
Terminated
·Sterile Surgical Systems Llc·Product code FYA·June 4, 2002
Sterilized gowns and towels. LINEN PACK II - contains 12 towels, 1 each large gortex scrub nurse gown/towel, 1 each extra large surgeons gown/towel, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***
FDA Recall
Terminated
·Sterile Surgical Systems Llc·Product code FYA·June 4, 2002
Sterile gowns and towels in packages. LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers. Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***''.
FDA Recall
Terminated
·Sterile Surgical Systems Llc·Product code FYA·June 4, 2002
Sterilized gowns and towels. C-Section Pack - contains 8 towels, 1 each large single-ply scrub nurse gown/towel, 2 each large gortex surgeons gown/towel, 2 each 36'' re-usable wrappers, 1 24'' re-usable wrapper. Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***.
FDA Recall
Terminated
·Sterile Surgical Systems Llc·Product code FYA·June 4, 2002
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 7, 2018
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018