49 results
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14ms
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Sources: EU EUDAMED, US FDA
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
FDA Recall
Open, Classified
·CardioFocus, Inc.·Product code OAE·February 7, 2025
Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.
FDA Recall
Open, Classified
·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWS·December 2, 2020
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code LWS·December 2, 2020
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code HIS·December 26, 2025
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code MCY·May 15, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code OLO·August 7, 2024
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code LPH·December 21, 2021
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code KTT·December 21, 2021
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024