Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 3,251–3,300 of 7,959

Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Class II
Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Produc
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Class II
Medical Device Recall · May 9, 2025
Philips Respironics, Inc.
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilat
This device does not indicate for use in patients with respiratory failure.
Class I
Medical Device Recall · May 8, 2025
BALT USA, LLC
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 008100685
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II
Medical Device Recall · May 8, 2025
CareFusion 303, Inc.
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES /
Antivirus software was not consistently installed on impacted devices during the implementation process.
Class II
Medical Device Recall · May 8, 2025
Ohio Medical Corporation
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
Class II
Medical Device Recall · May 8, 2025
CareFusion 303, Inc.
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352]
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Class II
Medical Device Recall · May 8, 2025
BALT USA, LLC
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II
Medical Device Recall · May 7, 2025
Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Class II
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Beckman Coulter, Inc.
DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Class II
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
Zyno Medical LLC
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Class I
Medical Device Recall · May 7, 2025
LUMITHERA INC
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration C
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Class III
Medical Device Recall · May 7, 2025
Medtronic MiniMed, Inc.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Class II
Medical Device Recall · May 7, 2025
MicroAire Surgical Instruments, LLC
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: Sma
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Class II
Medical Device Recall · May 6, 2025
Baxter Healthcare Corporation
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E1
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Class II
Medical Device Recall · May 6, 2025
Copan WASP
PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Descripti
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems u
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Olympus Corporation of the Americas
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TF
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II
Medical Device Recall · May 6, 2025
Hardy Diagnostics
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Class II
Medical Device Recall · May 5, 2025
Dexcom, Inc.
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Class II
Medical Device Recall · May 5, 2025
Beckman Coulter, Inc.
Access Testosterone assay, Catalog Number 33560
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Class II
Medical Device Recall · May 5, 2025
Olympus Corporation of the Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Class II
Medical Device Recall · May 5, 2025
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-se
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Class II
Medical Device Recall · May 2, 2025
ICU Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Class II
Medical Device Recall · May 2, 2025
Healthmark Industries Co., Inc.
Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 2, 2025
Canary Medical, Inc.
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System
Due to labeling error. Product incorrectly labeled.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 2, 2025
Healthmark Industries Co., Inc.
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 2, 2025
Copan Italia
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Swabs for specimen collection may be prone to breakage during product usage.
Class II
Medical Device Recall · May 2, 2025
Cardinal Health 200, LLC
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II
Medical Device Recall · May 1, 2025
Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class II
Medical Device Recall · May 1, 2025
Straumann USA LLC
GM Helix Acqua Implant, Article Number: 140.985
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class II
Medical Device Recall · May 1, 2025
Implant Direct Sybron Manufacturing LLC
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit i
The Drill stop kit contains incorrect components.
Class II
Medical Device Recall · May 1, 2025
Civco Medical Instruments Co. Inc.
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
Class II
Medical Device Recall · May 1, 2025
Remel, Inc
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Product may have an off color affecting perfomance
Class II
Medical Device Recall · May 1, 2025
SunMed Holdings, LLC
Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.
Class I
Medical Device Recall · April 30, 2025
BioFire Diagnostics, LLC
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
Class II
Medical Device Recall · April 30, 2025
Beckman Coulter Mishima K.K.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
Class II
Medical Device Recall · April 30, 2025
Beckman Coulter Mishima K.K.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
Class II
Medical Device Recall · April 30, 2025
Maquet Cardiopulmonary Ag
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Class II
Medical Device Recall · April 29, 2025
Fresenius Medical Care Holdings, Inc.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number:
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Class II