58 results
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Sources: EU EUDAMED, US FDA
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1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14; 5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04; 6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11; 7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12; 8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02; 9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88 10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·May 2, 2018
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
FDA Recall
Open, Classified
·Genicon, Inc.·Product code FZP·September 17, 2020
ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JJE·March 19, 2004
Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
FDA Recall
Terminated
·Cepheid·Product code NJR·April 1, 2011
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
FDA Recall
Terminated
·QLT USA, Inc.·Product code LYC·January 26, 2006
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JQP·September 17, 2018
Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.
FDA Recall
Terminated
·Eli Lilly and Company·Product code KMJ·March 17, 2011
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLI·February 20, 2014
VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, Ref #874 4468, 100 coated wells. Firm on label: Ortho-Clinical Diagnostics, Amersham UK.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code KLI·March 15, 2005
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
FDA Recall
Terminated
·Optovue, Inc.·Product code HLI·July 27, 2017
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code KLI·March 10, 2020
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code KLI·June 29, 2017
NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
FDA Recall
Open, Classified
·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022
inLight Medical LED Pads used with Polychromatic light technology system
FDA Recall
Terminated
·Inlightened Partners LLC·Product code ILY·June 4, 2019
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A
FDA Recall
Open, Classified
·THOR Photomedicine Ltd
2 Anglo Office Park
Units 1 &; 67 White Lion Road
Amersham United Kingdom·Product code ILY·July 24, 2025
Access Total T4 Calibrator, Catalog No. 33805
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KLI·March 16, 2026
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
FDA Recall
Terminated
·Cutera Inc·Product code ILY·May 8, 2010
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
FDA Recall
Terminated
·Quasar Bio-Tech, Inc. dba Silver Bay LLC·Product code ILY·October 25, 2012