249 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021
SOMATOM Definition AS-Computed tomography system Model 8098027
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021
SOMATOM Definition Edge -Computed tomography system Model 10590000
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code JAK·November 19, 2021
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWM·November 7, 2014
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code LTT·July 24, 2025
Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc 1 - Thumb Control Ring Piston Syringe (Catheter Tip), 60 cc 1- Graduated Solution Container, 500 cc, 1 - Underpad, 1-Sterile Alcohol Prep Pad Reorder No. 37-104 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Intended use: The trays are irrigation trays for catheters
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-103 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use Disposable Latex-Free Contents: 1 - Graduated Tray, 1200 cc 1 - Green Bulb Syringe (Catheter Tip), 60 cc 1 - Graduated Solution Container, 500 cc 1- Underpad, 1 - Sterile Alcohol Prep Pad Reorder No. 37-103 Contents STERILE in unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Usage: The trays are irrigation trays for catheters
FDA Recall
Terminated
·Nurse Assist, Inc·Product code FCM·January 20, 2011
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
FDA Recall
Terminated
·Product code GEH·March 25, 2015
Integra, Licox Ref 1P2.P; Brain PMO-Probe Kit Rx only; Contains Products: REF 1P2 Bolt kit for 2 Brain probes, REF CC1/P1 Combined Oxygen & Temperature Probe. Contents Sterile and Non-Pyrogenic if package is unopened and undamaged.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWM·February 18, 2010
Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·November 16, 2005
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNL·January 1, 2006
Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code KOD·December 4, 2023
(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A
FDA Recall
Terminated
·Arrow International Inc·Product code DQX·December 22, 2017
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; Contains sterile and non-pyrogenic if package is unopened and undamaged. Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code GWM·September 15, 2010
Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON LATEX FREE Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-14 FR Plastic Catheter Reorder No. 37-231 Contents STERILE In unopened, undamaged package. Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·January 20, 2011
Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free Contents: 1-Graduated Tray, 1200 cc, 1-Pair of Vinyl Gloves, 1-Fenestrated Drape, 1-Pack of Three PVP Swabsticks, 1-Specimen Container with Lid and Label, 1-Polylined Drape, 1-Pack of Lubricating Jelly, 1-30 cc Syringe, Pre-Filled with Sterile Water Reorder No. 37-234 Contents STERILE In unopened, undamaged package. Marketed by McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Intended use: The trays are urological catheter trays.
FDA Recall
Terminated
·Nurse Assist, Inc·Product code KOD·January 20, 2011
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
FDA Recall
Terminated
·Product code GEH·November 10, 2014
Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/AB-05060-PK; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/ASK-19609-VCU; CONTINUOUS NERVE BLOCK KIT/ASK-19600-CC2; CONTINUOUS NERVE BLOCK KIT 19 GA X 60/ASK-19608-CC; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-KP; CONTINUOUS NERVE BLOCK KIT 19GA X 60CM/ASK-19608-SHC; FLEXBLOCK KIT:ECHO CATH, 17Gx8CM STM NDL/FB-19608-K; FLEXBLOCK ULTRASOUND KIT: 17Gx8CM STM ND/FB-19608-KU; FLEXBLOCK KIT:ECHO CATH, 17Gx9CM NS NDL/FB-19609-K; FLEXBLOCK ULTRASOUND KIT: 17Gx9CM NS NDL/FB-19609-KU; CONTINUOUS PERIPHERAL NERVE BLOCK KIT/ASK-19608-US1; EPIDURAL CATHETERIZATION KIT/ASK-05001-SLR1; EPIDURAL CATHETERIZATION KIT/MH-05001; EPIDURAL CATHETERIZATION KIT/WJ-05401; SPINAL ANES/EPIDURAL CATH 19GA X 90CM/ASK-05501-USC1; EPIDURAL NEEDLE KIT/LG-03000; EPIDURAL ANESTHESIA KIT/MTO-03000-VM; EPIDURAL ANESTHESIA KIT/SM-03001; Anesthesia conduction kit/FB-19611-K
FDA Recall
Open, Classified
·ARROW INTERNATIONAL, LLC·Product code CAZ·April 21, 2026