January 17, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, lig
Hazard: Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
January 17, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, l
Hazard: Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
January 17, 2024Medical DevicesFDA
Bard Peripheral Vascular Inc recalls Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G
Hazard: The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
January 17, 2024Medical DevicesFDA
Becton, Dickinson and Company, BD Biosciences recalls CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Hazard: In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
January 17, 2024Medical DevicesFDA
Philips Healthcare (Suzhou) Co., Ltd. recalls Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Hazard: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.
January 10, 2024Medical DevicesFDA
Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Hazard: Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.
January 10, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B
Hazard: The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
January 10, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remote
Hazard: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
January 10, 2024Medical DevicesFDA
Natus Medical Incorporated recalls EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Hazard: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
January 10, 2024Medical DevicesFDA
Natus Medical Incorporated recalls External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Hazard: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
January 10, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Hazard: One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
January 10, 2024Medical DevicesFDA
Beaver Visitec International, Inc. recalls Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Hazard: One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
January 10, 2024Medical DevicesFDA
Covidien recalls Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Hazard: Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
January 10, 2024Medical DevicesFDA
Keystone Industries recalls KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua
Hazard: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
January 10, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2
Hazard: The sterility of microcatheter and infusion system devices cannot be guaranteed.
January 10, 2024Medical DevicesFDA
Encore Medical, LP recalls REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Hazard: Mislabeling
January 10, 2024Medical DevicesFDA
Encore Medical, LP recalls Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Hazard: Mislabeling
January 10, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C
Hazard: A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
January 10, 2024Medical DevicesFDA
Medtronic Inc. recalls Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Hazard: Seal defects could compromise the ability of the product packaging to maintain sterility.
January 10, 2024Medical DevicesFDA
ROi CPS LLC recalls Regard Dressing change kit, Item Number 800026006
Hazard: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Hazard: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Hazard: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
January 10, 2024Medical DevicesFDA
Busse Hospital Disposables, Inc. recalls Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Hazard: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
January 10, 2024Medical DevicesFDA
Insulet Corporation recalls Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap
Hazard: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
January 3, 2024Medical DevicesFDA
DeRoyal Industries Inc recalls DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Hazard: Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
January 3, 2024Medical DevicesFDA
Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
Hazard: A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
January 3, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Hazard: Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
January 3, 2024Medical DevicesFDA
Acumed LLC recalls RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an
Hazard: Due to potential breakage during use.