Medical Device Recalls

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7,979 medical device recalls from federal enforcement feeds.

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Showing 7,851–7,900 of 7,979

Medical Device Recall · November 6, 2023
Sarnova HC, Llc
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Class II
Medical Device Recall · November 6, 2023
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class II
Medical Device Recall · November 6, 2023
Merit Medical Systems, Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class II
Medical Device Recall · November 6, 2023
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Class II
Medical Device Recall · November 6, 2023
Randox Laboratories Ltd.
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxopla
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.
Class III
Medical Device Recall · November 6, 2023
Sarnova HC, Llc
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Class II
Medical Device Recall · November 2, 2023
Fujifilm Irvine Scientific, Inc.
Sperm separation media are used to separate motile sperm from other constituents of semen.
The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Class II
Medical Device Recall · November 1, 2023
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
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.
Class II
Medical Device Recall · November 1, 2023
Turncare, Inc
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Class II
Medical Device Recall · October 30, 2023
Folsom Metal Products, Inc.
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lig
Units were not intended for commercial distribution and inadvertently distributed.
Class II
Medical Device Recall · October 30, 2023
KENT IMAGING, INC.
Snapshot NIR, REF: KD204
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Class II
Medical Device Recall · October 30, 2023
Folsom Metal Products, Inc.
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Sma
Units were not intended for commercial distribution and inadvertently distributed.
Class II
Medical Device Recall · October 25, 2023
PHASE SCIENTIFIC INTERNATIONAL LIMITED
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.
Class II
Medical Device Recall · October 25, 2023
Becton, Dickinson and Company, BD Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
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.
Class II
Medical Device Recall · October 24, 2023
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
Class III
Medical Device Recall · October 24, 2023
GRAPHENANO DENTAL SL
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090;
Machining error on cams renders the device unusable.
Class II
Medical Device Recall · October 19, 2023
Abbott Laboratories
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest p
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Class II
Medical Device Recall · October 19, 2023
Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing p
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Class II
Medical Device Recall · October 19, 2023
Abbott Laboratories
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Class II
Medical Device Recall · October 16, 2023
Zimmer Biomet Spine Inc.
Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
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.
Class II
Medical Device Recall · October 16, 2023
MEDLINE INDUSTRIES, LP - Northfield
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile;
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Class I
Medical Device Recall · October 16, 2023
MEDLINE INDUSTRIES, LP - Northfield
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Class I
Medical Device Recall · October 16, 2023
MEDLINE INDUSTRIES, LP - Northfield
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
Class I
Medical Device Recall · October 11, 2023
Mc3 Inc
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 4
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
Class II
Medical Device Recall · October 11, 2023
Mc3 Inc
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145;
May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer
Class II
Medical Device Recall · October 10, 2023
Beaver Visitec International, Inc.
Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
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.
Class II
Medical Device Recall · October 6, 2023
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
Class II
Medical Device Recall · October 6, 2023
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
Class II
Medical Device Recall · October 6, 2023
Peter Lazic Gmbh
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
Class II
Medical Device Recall · October 5, 2023
CareFusion 303, Inc.
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD P
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.
Class II
Medical Device Recall · October 5, 2023
Encore Medical, LP
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Mislabeling
Class II
Medical Device Recall · October 5, 2023
Encore Medical, LP
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Mislabeling
Class II
Medical Device Recall · October 4, 2023
Visgeneer, Inc.
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
Class II
Medical Device Recall · October 4, 2023
Visgeneer, Inc.
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Due to products distributed without premarket clearance or approvals.
Class II
Medical Device Recall · October 2, 2023
Edge Biologicals Inc
Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the
Due to product outer packaging incorrectly labeled.
Class II
Medical Device Recall · September 25, 2023
Olympus Corporation of the Americas
Insufflation unit, UHI-4.
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
Class II
Medical Device Recall · September 23, 2023
Townsend Design
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036,
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Class II
Medical Device Recall · September 23, 2023
Townsend Design
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Class II
Medical Device Recall · September 23, 2023
Townsend Design
SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
Class II
Medical Device Recall · September 19, 2023
NeuroSync, Inc.
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field cas
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
Class II
Medical Device Recall · September 14, 2023
Hologic, Inc.
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstit
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Class II
Medical Device Recall · September 14, 2023
Olympus Corporation of the Americas
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for e
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYST
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-2015
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 2500105
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Onkos Surgical, Inc.
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-
Potential for breach of Tyvek seals.
Class II
Medical Device Recall · September 1, 2023
Angel Medical Systems, Inc.
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event
Device reaching End of Service prematurely.
Class II
Medical Device Recall · August 29, 2023
Limacorporate S.p.A
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degre
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
Class II