Medical Device Recalls
RSS ↗8,553 medical device recalls from federal enforcement feeds.
Showing 1,051–1,100 of 8,553
- 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 6, 2026
The intended use is to be paired with a weapon for aiming purposes.Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be returned to implement this change.
- Class II
Medical Device Recall · April 6, 2026
INZONE DETACHMENT SYSTEM, REF: M00345100950Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
- 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 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 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 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
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecoloDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
- 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
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. OptionalDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
- 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 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
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes ProsthesisDue to incorrect functional length on device labeling.
- 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 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 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
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy forDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
- 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 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 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
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 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
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire
- 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 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 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 2, 2026
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYcatheter may experience resistance when being advanced over the guidewire
- 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 K in vitro diagnostic test REF: 81A4The 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
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
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 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
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
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
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
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 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 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.
- Class II
Medical Device Recall · March 30, 2026
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula CompTen complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
- Class II
Medical Device Recall · March 27, 2026
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant AbutmentsIncludes an incorrect screw seat interface.
- Class I
Medical Device Recall · March 27, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at thKits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
- Class II
Medical Device Recall · March 27, 2026
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant AbutmentsIncludes an incorrect screw seat interface.
- Class II
Medical Device Recall · March 27, 2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOLabeling update to provide warning if functionality of the valve replacement delivery system is compromised.