Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-07-02FDA-DeviceEncore Medical, LPClass IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many pati
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- 2025-07-02FDA-DeviceEncore Medical, LPClass IIBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many pati
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceBecton Dickinson Infusion Therapy Systems, Inc.Class IIREF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
- 2025-07-02FDA-DeviceJolife ABClass IILUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
- 2025-07-02FDA-DeviceBIGFOOT BIOMEDICALClass IIBigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
- 2025-07-02FDA-DeviceBeckman Coulter, Inc.Class IIDxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
- 2025-07-02FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMedline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
- 2025-07-02FDA-DeviceBarco N.V.Class IIModel: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
- 2025-07-02FDA-DeviceIntegra LifeSciences Corp. (NeuroSciences)Class IMicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Lack of sterility assurance.
- 2025-07-02FDA-DeviceIntegra LifeSciences Corp. (NeuroSciences)Class IExtended Tip Applicator 8CM, Box of 1.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-07-02FDA-DeviceIntegra LifeSciences Corp. (NeuroSciences)Class IExtended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-07-02FDA-DeviceIntegra LifeSciences Corp. (NeuroSciences)Class IExtended Tip Applicator, 8CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-07-02FDA-DeviceSunMed Holdings, LLCClass IBroselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
- 2025-06-25FDA-DeviceDiagnostica Stago, Inc.Class IISTA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
- 2025-06-25FDA-DeviceFresenius Medical Care Holdings, Inc.Class II5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
- 2025-06-25FDA-DeviceICU Medical, Inc.Class IIICU Medical Plum Solos, Item number 400011001; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
- 2025-06-25FDA-DeviceICU Medical, Inc.Class IIICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
- 2025-06-25FDA-DeviceBALT USA, LLCClass IIPrestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 0081006856
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- 2025-06-25FDA-DeviceBALT USA, LLCClass IIOptima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 0081805302646
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- 2025-06-25FDA-DevicePreat CorpClass IIBiomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
- 2025-06-25FDA-DeviceChamberlain Technologies LLCClass IISURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Potential presence of residual adhesive material on the mesh surface.
- 2025-06-25FDA-DeviceChamberlain Technologies LLCClass IISURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Potential presence of residual adhesive material on the mesh surface.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief