2,969 results
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Sources: EU EUDAMED, US FDA
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Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
FDA Recall
Open, Classified
·Product code OEZ·January 7, 2026
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·November 16, 2011
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FMG·October 2, 2025
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021
Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.
FDA Recall
Open, Classified
·SunMed Holdings, LLC·Product code BTM·October 11, 2023
Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, Product ID # 730MM.
FDA Recall
Terminated
·Unomedical·Product code BTM·October 6, 2009
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code DRS·March 31, 2021
Flexgard, off-the-shelf knee brace, product number 14761106
FDA Recall
Terminated
·De Royal Industries·Product code ITQ·February 14, 2003
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL
FDA Recall
Open, Classified
·Smiths Medical Asd Inc·Product code DRS·November 10, 2023
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·April 17, 2012
FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·April 9, 2021
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQO·April 17, 2012
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
FDA Recall
Open, Classified
·Product code FKG·January 8, 2026
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
FDA Recall
Open, Classified
·Zimmer, Inc.·Product code PHX·May 20, 2026
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
FDA Recall
Terminated
·Avid Medical, Inc.·Product code OEZ·April 9, 2021