Retractor, Fiberoptic
Gastroenterology, Urology · 21 CFR 876.4530
Recent MDR events
89 adverse event reports on file
- BOSS INSTRUMENTSMar 13, 2026MalfunctionBoss Instruments, Ltd24589563
- MINI VERSALIGHT W/EXTENDED FRAZIER TIPApr 23, 2025MalfunctionBoss Instruments, Ltd21889979
- BOSS MINI VERSALIGHTApr 23, 2025MalfunctionBoss Instruments, Ltd21890335
- SNOWDEN-PENCERJul 18, 2024MalfunctionCarefusion Inc.1923569-2024-01012
- FIBEROPTIC RETRACTOR HANDLEApr 3, 2024MalfunctionCarefusion Inc.1923569-2024-01007
- FIBEROPTIC RETRACTOR HANDLEApr 3, 2024MalfunctionCarefusion Inc.1923569-2024-01008
- FIBER OPTIC LIGHT CABLEOct 26, 2023MalfunctionGulf Fiberoptics, Inc.18011499
- TEBBETTS FIBEROPTIC SS RETR 15CMX30MMJan 13, 2023InjuryCarefusion - St. Louis1923569-2023-00002
- TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDEJul 22, 2022MalfunctionCarefusion, Inc1923569-2022-00003
- TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDEJul 22, 2022MalfunctionCarefusion, Inc1923569-2022-00004
Event type breakdown
Recalls
2 recall events for this product code
- Lumitex IncTerminatedSep 3, 2009
Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/
Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.
Z-1998-2009 · View FDA record ↗ - Biomet Microfixation, Inc.TerminatedNov 28, 2008
Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485.
Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
Z-0415-2009 · View FDA record ↗
Registered firms
76 firms currently registered for this product code
Isomedix Operations Inc.
SPARTANBURG, SC, US
Vitalcor, Inc.
WESTMONT, IL, US
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Br Surgical Llc
Jacksonville, FL, US
Remington Medical, Inc.
Alpharetta, GA, US
Sterigenics Us Llc
Gurnee, IL, US
Weco Manufacturing Group-henrietta
Rochester, NY, US
Swantia Medical Private Limited
Sialkot Punjab, PK
Aspen Surgical Products, Inc.
Caledonia, MI, US
My Medical Store Llc
Fort Lauderdale, FL, US
Hayden Medical Inc
Valencia, CA, US
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Teleflex Medical Llc
Morrisville, NC, US
Olive Branch Distribution Center
Olive Branch, MS, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Heinrich Medizintechnik Gmbh
Stuttgart Baden-Wurttemberg, DE
Hexamed Pvt Ltd
Sialkot Punjab, PK
Depuy Synthes Sales
Bridgewater, MA, US
Erchinger Ag
TUTTLINGEN Baden-Wurttemberg, DE
Synthes (usa) Products Llc
West Chester, PA, US
Centurion Medical Products, Lp
Williamston, MI, US
In'tech Medical Sas
RANG DU FLIERS Pas-de-Calais, FR
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US