Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 4,301–4,350 of 7,959
- Class II
Medical Device Recall · December 3, 2024
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-Reports of various packaging issues that may result in a breach of the sterile barrier.
- Class II
Medical Device Recall · December 2, 2024
McKesson Cardiology Hemo softwareSoftware defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
- Class II
Medical Device Recall · December 2, 2024
Change Healthcare Cardiology Hemodynamics softwareSoftware 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
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA632A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- Class II
Medical Device Recall · December 2, 2024
Change Healthcare Cardiology Hemo softwareSoftware 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
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- Class II
Medical Device Recall · December 2, 2024
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064Platelet 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
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 · November 29, 2024
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
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 I
Medical Device Recall · November 27, 2024
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 27, 2024
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
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 II
Medical Device Recall · November 27, 2024
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 ConcentratThe devices were inadvertently shipped after their expiration date.
- Class II
Medical Device Recall · November 27, 2024
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 I
Medical Device Recall · November 27, 2024
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 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: E6-1222The 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
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 thDue to an increase of complaints for bracket bond failures and skin irritation or blistering.
- Class II
Medical Device Recall · November 26, 2024
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 usingBeckman 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
Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/AElevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
- Class II
Medical Device Recall · November 25, 2024
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100Potential 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 Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 SoftwThe probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Class II
Medical Device Recall · November 25, 2024
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 OTWDue 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
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
- 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: N542The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Class II
Medical Device Recall · November 25, 2024
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
- 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: N5The 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: N5The 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,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54The 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, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: NThe probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Class II
Medical Device Recall · November 25, 2024
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8)GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
- Class II
Medical Device Recall · November 25, 2024
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
- 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: N54The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Class II
Medical Device Recall · November 25, 2024
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be providedGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
- Class II
Medical Device Recall · November 25, 2024
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MBGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
- 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: N542The 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, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5The 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: N54The 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,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N54The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Class II
Medical Device Recall · November 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 24, 2024
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;Lack of 510(k) clearance.
- Class II
Medical Device Recall · November 22, 2024
3M Company - Health Care Business
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837Attachments may not mate with the tooth as intended in the digital treatment design.