Medical Device Recalls
RSS ↗7,493 medical device recalls from federal enforcement feeds.
Showing 51–100 of 7,493
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 10, 2026
Stryker Sustainability Solutions
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product
- Class II
Medical Device Recall · April 9, 2026
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irriDue to nonconforming products being inadvertently distributed.
- Class II
Medical Device Recall · April 8, 2026
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2,Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Class II
Medical Device Recall · April 8, 2026
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900BSoftware issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- Class II
Medical Device Recall · April 8, 2026
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NComplaints have been received of systems developing loose, missing, or broken internal bolts over time.
- Class II
Medical Device Recall · April 7, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
- Class II
Medical Device Recall · April 7, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useBD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
- Class II
Medical Device Recall · April 6, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mmStent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- Class II
Medical Device Recall · April 6, 2026
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Product has the potential for false positive results
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Class II
Medical Device Recall · April 2, 2026
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire
- Class II
Medical Device Recall · April 2, 2026
One Step UTI in vitro diagnostic test REF: 3374The devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407The devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
One Step 10A in vitro diagnostic testThe devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
Uric Acid in vitro diagnostic test REF: 31H0PThe devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
- Class II
Medical Device Recall · April 2, 2026
One Step pH in vitro diagnostic test REF: 31I4PThe devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire
- Class II
Medical Device Recall · April 2, 2026
One Step K in vitro diagnostic test REF: 81A4The devices were distributed without required FDA premarket clearance or approval.
- Class I
Medical Device Recall · April 2, 2026
Windstone Medical Packaging, Inc.
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908FAffected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
- Class I
Medical Device Recall · April 2, 2026
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NRMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- Class II
Medical Device Recall · April 2, 2026
One Step P in vitro diagnostic test REF: 8194The devices were distributed without required FDA premarket clearance or approval.
- Class II
Medical Device Recall · April 2, 2026
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire
- Class II
Medical Device Recall · April 2, 2026
Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systDue to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Class I
Medical Device Recall · April 2, 2026
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials aMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- Class I
Medical Device Recall · April 2, 2026
Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiograMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
- Class II
Medical Device Recall · April 1, 2026
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040AKits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Class II
Medical Device Recall · April 1, 2026
i-STAT EG6+ cartridge; List Number: 03P77-25;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- Class II
Medical Device Recall · April 1, 2026
i-STAT G3+ cartridge; List Number: 03P78-26;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- Class II
Medical Device Recall · April 1, 2026
i-STAT EG7+ cartridge; List Number: 03P76-25;Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
- Class II
Medical Device Recall · April 1, 2026
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485Respiratory/sore throat panel test may result in false negative results and control failures.
- Class II
Medical Device Recall · March 31, 2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
- Class II
Medical Device Recall · March 31, 2026
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- Class II
Medical Device Recall · March 31, 2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- Class II
Medical Device Recall · March 31, 2026
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for OlyDevices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
- Class II
Medical Device Recall · March 30, 2026
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, VersFor some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
- Class II
Medical Device Recall · March 30, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.