Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 4,051–4,100 of 7,959

Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXperFD20/15 System Code: (1) 722058
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Possibility of the patient falling from the table related to the mattress used on the patient table.
Class I
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 13, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Allura Xper FD20/20 System Code: (1) 722038
Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
Class II
Medical Device Recall · January 10, 2025
Integra LifeSciences Corp.
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey i
Potential that the induction seal is not completely sealed to the device tube packaging.
Class II
Medical Device Recall · January 10, 2025
CareFusion 303, Inc.
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
Class II
Medical Device Recall · January 10, 2025
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted r
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Class I
Medical Device Recall · January 10, 2025
Spectranetics Corporation
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; T
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Class I
Medical Device Recall · January 10, 2025
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Class II
Medical Device Recall · January 10, 2025
Nobel Biocare
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an en
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Class II
Medical Device Recall · January 9, 2025
Kung Shin Plastics Co. Ltd.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Class II
Medical Device Recall · January 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Class II
Medical Device Recall · January 9, 2025
Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
Class II
Medical Device Recall · January 9, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Class II
Medical Device Recall · January 9, 2025
Medtronic Neuromodulation
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1F
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II
Medical Device Recall · January 8, 2025
Hologic, Inc.
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party sup
Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN¿ for the TLiIQ¿ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 20
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
Class II
Medical Device Recall · January 8, 2025
Ithera Medical Gmbh
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using c
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Class II
Medical Device Recall · January 8, 2025
Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
Class II
Medical Device Recall · January 8, 2025
Stryker Corporation
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
Class II
Medical Device Recall · January 8, 2025
CareFusion 303, Inc.
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Class II
Medical Device Recall · January 6, 2025
Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Class II
Medical Device Recall · January 6, 2025
Sysmex America, Inc.
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cyto
Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
Class II
Medical Device Recall · January 6, 2025
Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
Class II
Medical Device Recall · January 5, 2025
Biosense Webster, Inc.
VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used
Due to an observed trend of neurovascular events
Class I
Medical Device Recall · January 3, 2025
LivaNova USA, Inc.
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Sti
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Class II
Medical Device Recall · January 3, 2025
LivaNova USA, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vag
Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Class II
Medical Device Recall · January 3, 2025
XTANT Medical Holdings, Inc
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Class II
Medical Device Recall · January 3, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Class II
Medical Device Recall · January 2, 2025
Scientia Vascular, Inc.
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute is
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Class II
Medical Device Recall · January 2, 2025
Beckman Coulter Inc.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
Class II
Medical Device Recall · January 2, 2025
US Endodontics, LLC
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP1
Due to devices being irradiated above the established specification which my result in package integrity issues.
Class II
Medical Device Recall · January 2, 2025
SIEMENS MEDICAL SOLUTIONS USA, INC
ARTIS One Angiographic X-Ray System
A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
Class II
Medical Device Recall · January 2, 2025
Belmont Instrument LLC
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
Class II
Medical Device Recall · December 31, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2) ARTERIAL LINE BUNDLE, Item Number ART255; 3) ARTERIAL LINE TRAY, Item Number ART350; 4) ARTERIAL LINE
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class I
Medical Device Recall · December 31, 2024
Exactech, Inc.
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Medical Device Recall · December 31, 2024
Exactech, Inc.
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Medical Device Recall · December 31, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class I
Medical Device Recall · December 31, 2024
Exactech, Inc.
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Class II
Medical Device Recall · December 28, 2024
Neilmed Pharmaceuticals Inc
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a sa
Due to nasal spray stability failure for bioburden.
Class II
Medical Device Recall · December 26, 2024
ROi CPS LLC
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Class I