FDA (Device enforcement)

11,102 recalls · page 9 of 112

• ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;2026-03-31
• ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-2222026-03-31
• Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 72222026-03-31
• Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A2026-03-30
• LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.52026-03-30
• LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.52026-03-30
• Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV712026-03-27
• AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indic2026-03-27
• Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic paramet2026-03-26
• Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-3002026-03-26
• Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-62026-03-26
• Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-232026-03-26
• Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-252026-03-26
• Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-152026-03-26
• Revolution Apex, X-ray Computed Tomography, Model Number 5590000-202026-03-26
• Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-272026-03-26
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21112026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-21122026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.2026-03-25
• OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.2026-03-25
• Oxoid Agglutinating Sera, Salmonella 9-0 R309573012026-03-25
• VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-0002026-03-25
• Heraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
• Heraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S2026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S2026-03-25
• DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-232026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-252026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S2026-03-25
• DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-272026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S2026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-252026-03-25
• DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S2026-03-25
• DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-272026-03-25
• BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC2026-03-25
• Yeastone Broth, 11ML, 10/BOX YY34622026-03-24
• Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.2026-03-24
• Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.2026-03-24
• Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure transducer2026-03-24
• Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, Medline Kit Number/SKUDYNJ23532C; 2. CATH LAB PACK, Medline Kit Number/SKUDYNJ65185; 3. ANGIO KIT, Medline Kit Number/SKUVASC1057.2026-03-24
• 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Med2026-03-24
• 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEART CATH PACK-LF, Medline Kit SKU Number: DYNJ0373285M; 4. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615P; 5. ANGIO DRAPE CARDIAC PACK, Medline Kit SKU Number: DYNJ51615R; 62026-03-24
• Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT,KIT, Medline Kit Number/SKU 60010508; 2. DBD-MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60160075; 3. CARDIAC CATH PACK, Medline Kit Number/SKU DYNJ04636N; 4. CATH LAB TRAY, Medline Kit Number/SKU DYNJ242026-03-24
• Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL39602026-03-24
• Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;2026-03-23
• Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" C2026-03-23
• Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.2026-03-23
• Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.112026-03-23
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.2026-03-19
• B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M20962026-03-19
• B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.2026-03-19
• B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.2026-03-19
• B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.2026-03-19
• B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.2026-03-19
• Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.2026-03-19
• Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
• Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
• Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
• Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
• Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
• Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ2026-03-19
• Brand Name: Leksell Vantage Arc System REF: 10539582026-03-19
• Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.25" X 0.25", XR, 10/PK, Medline SKU NEUROSPNG02; 2. Neuro Sponges, Eponges neuro, Neuroesponjas, size 0.5" X 0.5", XR, 10/PK, Medline SKU NEUROSPNG05; 3. Neuro Sponges, Eponges neuro, Neuroe2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT32702026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Ki2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.2026-03-19
• 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 Kit2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU2026-03-19
• Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS FREE FLAP, Medline Kit Number/SKU CDS983493N; 2. TLIF PACK, Medline Kit Number/SKU DYNJ02476O; 3. DONOR FREE FLAP PACK-LF, Medline Kit Number/SKU DYNJ0426069N; 4. DONOR FREE FLAP PACK-LF, Medline Kit Nu2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DY2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.2026-03-19
• Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS117152026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline Kit Number/SKU DYNJ37902F2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC381332026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEDURES PACK-LF, Medline Kit Number/SKU DYNJ0751220P; 2. ENSEMBLE RACHIS-LF, Medline Kit Number/SKU DYNJ47568B; 3. UROLOGY ROBOTIC, Medline Kit Number/SKU DYNJ55555B; 4. UROLOGY ROBOTIC, Medline Kit Num2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, 2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B2026-03-19
• Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.2026-03-19
• Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therap2026-03-19