40 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
FDA Recall
Open, Classified
·Stradis Healthcare·Product code PKD·December 15, 2022
Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·October 2, 2003
PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
FDA Recall
Terminated
·Rx Textiles Inc·Product code :·June 11, 2003
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
FDA Recall
Terminated
·Integra LifeSciences Corp. d.b.a. Integra Pain Management·Product code CAZ·August 24, 2016
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CEO·September 3, 2025
MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Viewray Incorporated·Product code IYE·August 27, 2015
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
FDA Recall
Open, Classified
·American Contract Systems Inc·Product code OJH·May 15, 2024
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
FDA Recall
Open, Classified
·American Contract Systems Inc·Product code OJH·May 15, 2024
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
FDA Recall
Open, Classified
·American Contract Systems Inc·Product code OJH·May 15, 2024
Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B
FDA Recall
Open, Classified
·Product code OJG·April 27, 2026
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
FDA Recall
Terminated
·Product code GAM·June 6, 2007
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code KHS·April 5, 2023
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JHS·June 12, 2013
MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction of tumors.
FDA Recall
Terminated
·Mira, Inc.·Product code HPS·April 8, 2010
ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018
CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01
FDA Recall
Open, Classified
·Beaver Visitec International, Inc.·Product code HPS·March 17, 2023