Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-05-11FDA-DeviceOlympus Corporation of the AmericasClass IIUltrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
- 2022-05-11FDA-DeviceJohnson & Johnson Surgical Vision IncClass IITRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Potential breach in the sterility barrier for tray ring covers.
- 2022-05-11FDA-DeviceASO LLCClass IIFirst Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)
Kits contained recalled acetaminophen.
- 2022-05-11FDA-DeviceAcera Surgical IncClass IIRestrata, Part Number RWM1-2X2
Misprinted expiration date on the shelf-box
- 2022-05-11FDA-DeviceDePuy Orthopaedics, Inc.Class IIVELYS Robotic-Assisted Solution Base Product No.: 451570100
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
- 2022-05-11FDA-Devicerestor3d Inc.Class IIEvans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
- 2022-05-11FDA-Devicerestor3d Inc.Class IIEvans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
- 2022-05-11FDA-Devicerestor3d Inc.Class IINon-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- 2022-05-11FDA-DeviceBaxter Healthcare CorporationClass IIFlo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
There is a potential for foreign matter.
- 2022-05-11FDA-DeviceBecton Dickinson & Co.Class IIBD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes.
- 2022-05-11FDA-DeviceSML Distribution, LLCClass ISkippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
- 2022-05-11FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAzurion systems with software release R1.x
In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
- 2022-05-04FDA-DeviceFreudenberg Medical, LlcClass IIEmpower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- 2022-05-04FDA-DeviceFreudenberg Medical, LlcClass IIEmpower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- 2022-05-04FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIIMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
- 2022-05-04FDA-DeviceInstrumentation LaboratoryClass IIACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 CL 00000280097
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
- 2022-05-04FDA-DeviceWaters Medical Systems LLCClass IIWAVES WCM Kidney Cassette Module
There is a potential for the WCM cassette pump head leaking solution.
- 2022-05-04FDA-DeviceDraegar Medical Systems, Inc.Class IIDrager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Software issue resulting in temporary loss of central monitoring functionality.
- 2022-05-04FDA-DeviceStryker GmbHClass IISmart Toe II Intramedullary Arthrodesis Implant
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
- 2022-05-04FDA-DeviceSiemens Medical Solutions USA, Inc.Class IIAcuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Transducers (component of ultrasound system) may exceed recommended thermal index limits
- 2022-05-04FDA-DeviceRoche Diabetes Care, Inc.Class IIRocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
- 2022-05-04FDA-DeviceCarl Zeiss Meditec AGClass IIZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
High friction of the slider can cause the device to stick, or not move as intended.
- 2022-05-04FDA-DeviceROi CPS LLCClass IIConvenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
- 2022-05-04FDA-DeviceROi CPS LLCClass IIConvenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
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