Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 4,401–4,450 of 8,689
- Class II
Medical Device Recall · February 25, 2025
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Floor mounting column TruSystem 7500, Product Code 1717021There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500 U, Product Code 1730731There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Mobile column TruSystem 7500 U, Product Code 1730720There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Mobile column TruSystem 7500, Product Code 1717023There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
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 tA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Class II
Medical Device Recall · February 25, 2025
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
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 (birthA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500, Product Code 4091000There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Baxter Floor mounting column TS 7500 U, Product Code 1730732There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
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 toA wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Class II
Medical Device Recall · February 25, 2025
Baxter Stationary column TruSystem 7500, Product Code 1717020There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITLThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 25, 2025
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, P7520A24SThe air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- Class II
Medical Device Recall · February 25, 2025
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208SThere is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- Class II
Medical Device Recall · February 25, 2025
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- Class II
Medical Device Recall · February 24, 2025
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint GuardianAdhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.
- Class II
Medical Device Recall · February 24, 2025
DePuy Mitek, Inc., a Johnson & Johnson Co.
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.Device is missing the pin in the graft loader component.
- Class II
Medical Device Recall · February 24, 2025
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint GuardiAdhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.
- Class II
Medical Device Recall · February 24, 2025
DePuy Mitek, Inc., a Johnson & Johnson Co.
COR Disposable Kit, 8 mm. Cartilage Transplant System.Device is missing the pin in the graft loader component.
- Class I
Medical Device Recall · February 24, 2025
MEDLINE INDUSTRIES, LP - Northfield
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) NEWBORSpecific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
- Class II
Medical Device Recall · February 24, 2025
Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.
- Class I
Medical Device Recall · February 21, 2025
MEDLINE INDUSTRIES, LP - Northfield
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,Medline medical procedure kits, containing Medtronic Aortic Root Cannula
- Class I
Medical Device Recall · February 21, 2025
MEDLINE INDUSTRIES, LP - Northfield
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.Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
- Class I
Medical Device Recall · February 21, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LFMedical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
- Class I
Medical Device Recall · February 21, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACKMedical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
- Class II
Medical Device Recall · February 20, 2025
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution TranIVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
- Class II
Medical Device Recall · February 20, 2025
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065NThe A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
- Class II
Medical Device Recall · February 20, 2025
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044NThe RSV target may give a late Ct value and could potentially not pass QC.
- Class II
Medical Device Recall · February 20, 2025
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, 37mmThe product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
- Class II
Medical Device Recall · February 20, 2025
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 pressuDue to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
- Class II
Medical Device Recall · February 19, 2025
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 communWhen following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.
- Class II
Medical Device Recall · February 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
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 TOThere is a potential for the sterility of the device to be compromised.
- Class II
Medical Device Recall · February 19, 2025
Lazervida 10W diode laser cutter and engraver with Lazervida shield.Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.
- Class II
Medical Device Recall · February 19, 2025
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)There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
- Class II
Medical Device Recall · February 19, 2025
MEDLINE INDUSTRIES, LP - Northfield
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,BAThere is a potential for the sterility of the device to be compromised.