1,006 results · 12ms · Sources: EU EUDAMED, US FDA

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ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

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

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

FDA Recall
Open, Classified ·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023

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

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

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

HENRY SCHEIN, OMFS, Item No.570-2779,

FDA Recall
Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code OFX·November 2, 2022

1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

FDA Recall
Open, Classified ·Smiths Medical Asd Inc·Product code DRS·November 10, 2023

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

MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·November 15, 2023

BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)

FDA Recall
Open, Classified ·Becton Dickinson & Company·Product code FMG·May 9, 2022

Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A

FDA Recall
Open, Classified ·Product code DXT·February 25, 2026

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

FDA Recall
Open, Classified ·Product code OFX·March 19, 2026

Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.

FDA Recall
Open, Classified ·CHANGE HEALTHCARE CANADA COMPANY·Product code LLZ·April 19, 2021