Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 5,001–5,050 of 8,689

Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO S
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE S
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STE
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; gener
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Qualigen Inc
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Class III
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Stryker Corporation
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Class II
Medical Device Recall · December 3, 2024
Medicrea International
UNiD" 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 UN
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.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECO
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gyn
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 2, 2024
A L I Technologies Ltd
McKesson Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Class II
Medical Device Recall · December 2, 2024
MICROVENTION INC.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Class II
Medical Device Recall · December 2, 2024
Accriva Diagnostics, Inc.
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Class II
Medical Device Recall · December 2, 2024
Moximed, Inc.
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
Class II
Medical Device Recall · December 2, 2024
Coloplast Manufacturing US, LLC
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA632
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Class II
Medical Device Recall · December 2, 2024
A L I Technologies Ltd
Change Healthcare Cardiology Hemodynamics software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Class II
Medical Device Recall · December 2, 2024
Coloplast Manufacturing US, LLC
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522,
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Class II
Medical Device Recall · December 2, 2024
A L I Technologies Ltd
Change Healthcare Cardiology Hemo software
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Class II
Medical Device Recall · November 29, 2024
ConvaTec, Inc
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10)
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Class II
Medical Device Recall · November 27, 2024
IsoTis OrthoBiologics, Inc.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Class II
Medical Device Recall · November 27, 2024
IsoTis OrthoBiologics, Inc.
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Class II
Medical Device Recall · November 27, 2024
Trokamed GmbH
Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class I
Medical Device Recall · November 27, 2024
Trokamed GmbH
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class I
Medical Device Recall · November 27, 2024
Trokamed GmbH
Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class I
Medical Device Recall · November 27, 2024
3B Medical, Inc.
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrat
The devices were inadvertently shipped after their expiration date.
Class II
Medical Device Recall · November 27, 2024
Trokamed GmbH
Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Class I
Medical Device Recall · November 26, 2024
3M Unitek Corporation
3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in th
Due to an increase of complaints for bracket bond failures and skin irritation or blistering.
Class II
Medical Device Recall · November 26, 2024
Applied Medical Technology Inc
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Class II
Medical Device Recall · November 26, 2024
Beckman Coulter, Inc.
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
Class II
Medical Device Recall · November 26, 2024
O&M HALYARD, INC.
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spectranetics Corporation
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW
Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II