Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR PLASTIC PACK, Catalog Number:SEY35OP962 6) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96A 7) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96B 8) OCULAR PLASTIC PACK, Catalog Number:SEY35OP96C 9) OCULAR PLASTIC PACK, C
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:P
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CR
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Cata
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVAS
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCardinal Health 200, LLCClass IICardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Cata
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class IIBD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
- 2025-02-19FDA-DeviceMICROVENTION INC.Class IIMicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class II(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 No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
- 2025-02-19FDA-DeviceCareFusion 303, Inc.Class II(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
- 2025-02-19FDA-DeviceMax Mobility LLCClass IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- 2025-02-19FDA-DeviceMax Mobility LLCClass IMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.
- 2025-02-19FDA-DeviceIthera Medical GmbhClass IIThe 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 combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
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).
- 2025-02-19FDA-DeviceGetinge Usa Sales IncClass IVaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- 2025-02-19FDA-DeviceOlympus Corporation of the AmericasClass IOlympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6M
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- 2025-02-12FDA-DeviceMedicrea InternationalClass IIUNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Anal
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
- 2025-02-12FDA-DeviceBeckman Coulter, Inc.Class IIBeckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
- 2025-02-12FDA-DeviceUS Endodontics, LLCClass IIBrasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF: SX70421MM SX70425MM SX70429MM SX70621MM SX70625MM SX70629MM SX7170421RF SX7170425RF SX7170429RF SX7170621RF SX7170625RF SX7170629RF SX7200421RF SX7200425RF SX7200429RF SX7200621RF SX7200625RF SX720062
Due to devices being irradiated above the established specification which my result in package integrity issues.
- 2025-02-12FDA-DeviceSysmex America, Inc.Class IISysmex 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 cytometric analysis.
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.
- 2025-02-12FDA-DeviceBeckman Coulter Inc.Class IIAccess 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.
- 2025-02-12FDA-DeviceDDS LabClass IITemporary Titanium Abutments
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
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