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Sources: EU EUDAMED, US FDA
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Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
FDA Recall
Open, Classified
·SVS LLC·Product code LZC·May 13, 2024
MICRO-TOUCH(R), S (indicating size small), NITRILE, Powder Free, Medical Examination Gloves, REF 6034301, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code LZC·August 4, 2011
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
FDA Recall
Open, Classified
·O & M HALYARD INC·Product code LZC·September 27, 2021
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
FDA Recall
Open, Classified
·O & M HALYARD INC·Product code LZC·April 13, 2026
Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.
FDA Recall
Terminated
·Integra Pain Management·Product code LZC·July 7, 2008
MICRO-TOUCH(R), L (indicating size large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034303, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code LZC·August 4, 2011
MICRO-TOUCH(R), XL (indicating size extra large), NITRILE, Powder Free, Medical Examination Gloves, REF 6034304, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code LZC·August 4, 2011
MICRO-TOUCH(R), M (indicating size medium), NITRILE, Powder Free, Medical Examination Gloves, REF 6034302, 200 Pieces, Manufactured for: Ansell Healthcare - Made in Malaysia
FDA Recall
Terminated
·Ansell Healthcare Products LLC·Product code LZC·August 4, 2011
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
FDA Recall
Terminated
·LivaNova USA·Product code DWC·April 20, 2018
Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA.
FDA Recall
Terminated
·Joerns Healthcare Inc.·Product code FSA·January 6, 2006
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005
FDA Recall
Terminated
·Ameditech Inc·Product code DIO·August 18, 2020
Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code BZC·November 19, 2009
REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of the monitors is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia/recovery, in the intensive care unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code BZC·November 19, 2009
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013
Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
FDA Recall
Terminated
·Innovision A/S Skovvaenget 2 Glamsbjerg Denmark·Product code BZC·May 13, 2016
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZC·November 4, 2015
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic response study.
FDA Recall
Open, Classified
·Vyaire Medical, Inc. Leibnizstr. 7 Hochberg Germany·Product code BZC·April 8, 2024
TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
FDA Recall
Terminated
·Ormco Corporation·Product code DZC·March 15, 2011
Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon dioxide and pulse oximetry monitoring.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code BZC·November 19, 2009