49 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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WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code NGV·May 7, 2018
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NGV·August 25, 2015
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code NGV·August 25, 2015
SQ40S Blood Transfusion Filter
FDA Recall
Open, Classified
·GVS TM, Inc·Product code CAK·November 3, 2025
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code KNW·May 2, 2019
CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK TOWELS ABSORBENT 15" X 20" L/Free Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHOLE PACK-LF, Kit SKU DYNJ32836B; 7) MINOR SET UP PACK, Kit SKU DYNJ43272K; 8) PK, GEN LAPAROSCOPIC CHOLE, Kit SKU DYNJ43976C; 9) GV LAP CHOLE PACK, Kit SKU DYNJ46939Q; 10) LAP CHOLE PACK, Kit SKU DYNJ49688C; 11) GENERAL ROBOTIC LAP, Kit SKU DYNJ51347N; 12) LAP CHOLE PACK, Kit SKU DYNJ54081F; 13) PEDIATRIC MOSES, Kit SKU DYNJ58864B; 14) LAPAROTOMY PACK, Kit SKU DYNJ59313B; 15) CRMC LAP CHOLE DIAG LAP-LF, Kit SKU DYNJ61095F; 16) LAP GASTRIC PACK, Kit SKU DYNJ62065A; 17) MINOR PACK, Kit SKU DYNJ64174A; 18) GENERAL SURGERY PACK, Kit SKU DYNJ64258I; 19) GENERAL LAP SHARED-LF, Kit SKU DYNJ64786D; 20) CHOLE PACK, Kit SKU DYNJ67686B; 21) GEN SURG MINOR PACK, Kit SKU DYNJ69142F; 22) LAP CHOLE PACK, Kit SKU DYNJ81695B; 23) GENERAL LAPAROSCOPY, Kit SKU DYNJ900901K; 24) GEN MINOR, Kit SKU DYNJ900906L; 25) ROBOTIC GENERAL, Kit SKU DYNJ906861D; 26) RMC GENERAL LAPAROSCOPIC, Kit SKU DYNJ907087C; 27) LAP CHOLE LMC CDS, Kit SKU DYNJ911116A; 28) MINOR GENERAL PACK, Kit SKU DYNJT3884; 29) GENERAL LAPAROSCOPY PACK, Kit SKU DYNJT4504; 30) MINOR SURGERY PACK-LF, Kit SKU PHS109062D.
FDA Recall
Open, Classified
·Product code FDE·December 12, 2025
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code NAV·June 24, 2011
Menopause (FSH) 2 Tests
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code NGA·November 3, 2025
Menopause Test Cassette (Urine)
FDA Recall
Open, Classified
·Changchun Wancheng Bio-Electron Co., Ltd.
2336, Tianwei Road
Beihu Science and Technology Development Zone
Changchun China·Product code NGA·November 22, 2025
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code NAV·June 24, 2011
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM).
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code NAV·June 24, 2011
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
FDA Recall
Terminated
·X-NAV Technologies, LLC·Product code PLV·February 23, 2016
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·September 28, 2022
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.
FDA Recall
Terminated
·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code JAA·June 27, 2019
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code JEY·February 3, 2020
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.
FDA Recall
Terminated
·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IWZ·January 25, 2019
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
FDA Recall
Terminated
·Materialise N.V. Technologielaan 15 Heverlee Belgium·Product code KWS·July 17, 2020