52 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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Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: A stretcher used for eye surgery.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010
Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: Service parts are replacement parts for the eye surgery stretcher.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
FDA Recall
Terminated
·Oakworks Inc·Product code FNJ·April 21, 2022
Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed
FDA Recall
Terminated
·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005
Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNJ·September 16, 2009
Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FNJ·September 16, 2009
Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended Use: A stretcher used for eye surgery.
FDA Recall
Terminated
·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Recall
Terminated
·Micro-Tech (Nanjing) Co., Ltd.
High Tech
NO. 10 Gaoke Third Road Nanjing National
Nanjing China·Product code ODG·March 12, 2018
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
FDA Recall
Terminated
·Micro-Tech (Nanjing) Co., Ltd.
High Tech
NO. 10 Gaoke Third Road Nanjing National
Nanjing China·Product code ODG·March 12, 2018
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code ITX·September 25, 2023
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·November 18, 2019
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code JOS·November 18, 2019
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FCG·March 31, 2023
Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FCG·August 11, 2011
OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
FDA Recall
Terminated
·Olympus America Inc.·Product code FCG·August 25, 2011
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DRC·January 19, 2021
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a solid wire that when inserted in the needle protrudes beyond the distal tip of the cannula.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DRC·January 19, 2021
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6" FEMORAL ART LINE KIT, Model Number: ART1165; d. 3" RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6" FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRP·May 15, 2023
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSS·May 21, 2014