FDA (Device enforcement)

11,102 recalls · page 31 of 112

• Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.2025-02-25
• Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL2025-02-25
• Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL2025-02-25
• Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL2025-02-25
• Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL2025-02-25
• Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL2025-02-25
• Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL2025-02-25
• Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL2025-02-25
• Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL2025-02-25
• Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)2025-02-25
• Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL2025-02-25
• Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL2025-02-25
• Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S2025-02-25
• Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S2025-02-25
• Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S2025-02-25
• Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.2025-02-25
• Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.2025-02-25
• Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices.2025-02-25
• COR Disposable Kit, 8 mm. Cartilage Transplant System.2025-02-24
• COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.2025-02-24
• Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6) PEDS PURPLE, REF ACC010397; 7) 2025-02-24
• Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-00072025-02-24
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.2025-02-21
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK2025-02-21
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF2025-02-21
• Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK.2025-02-21
• Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.2025-02-20
• BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.2025-02-20
• MIM software; System, Image Processing, Radiological2025-02-19
• CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.2025-02-19
• VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.2025-02-19
• VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.2025-02-19
• VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.2025-02-19
• Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.2025-02-19
• GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 20882025-02-19
• GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.2025-02-19
• GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.2025-02-19
• Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) M2025-02-19
• Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMA2025-02-19
• GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution CT, System, X-ray, Tomography, Computed2025-02-18
• GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed2025-02-18
• BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software2025-02-18
• 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;2025-02-17
• 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;2025-02-17
• 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;2025-02-17
• 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;2025-02-17
• 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;2025-02-17
• 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;2025-02-17
• 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;2025-02-17
• Trial Tampon Box; Model Number: FG-TMP-REF04050504;2025-02-17
• All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;2025-02-17
• Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;2025-02-17
• Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;2025-02-17
• Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;2025-02-17
• Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;2025-02-17
• Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;2025-02-17
• Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;2025-02-17
• Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;2025-02-17
• Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;2025-02-17
• Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;2025-02-17
• Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;2025-02-17
• Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;2025-02-17
• Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;2025-02-17
• Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;2025-02-17
• Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;2025-02-17
• Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;2025-02-17
• Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;2025-02-17
• Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;2025-02-17
• Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;2025-02-17
• Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;2025-02-17
• Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infan2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICROSTREAM FilterLine Set Long Adu2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 0109912025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstream Advance Adult-Pediatric Intu2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microstream Advance Adult-Pediatric In2025-02-17
• Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/2025-02-17
• Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a p2025-02-15
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/112025-02-14
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/122025-02-14
• Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/132025-02-14
• CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW11002025-02-14
• CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW82142025-02-14
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-242025-02-13
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-242025-02-13
• smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-242025-02-13
• smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-242025-02-13
• smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-242025-02-13
• smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-242025-02-13
• Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/0352025-02-13
• Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threa2025-02-13