Product Name Or Brand
Start broad with the product name, manufacturer, retailer brand or model family. This is usually the fastest way to find a possible notice.
Start with the product name or brand. If the list is too broad, search the exact UPC, lot code, model number, date code, NHTSA campaign number or official recall number printed on the notice or label.
Results help you find a possible match quickly. Before you stop use, discard, return or repair anything, open the official notice and confirm every affected detail.
| Product Recall | Source | Type | Risk | Date | Action |
|---|---|---|---|---|---|
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
|
FDA
Z-1053-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 26, 2025
|
Details |
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit SKU DYNDV1691B; 5) OUTPATIENT 2 TO 5 YEARS, Medline kit SKU DYNDV2464A.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
|
FDA
Z-1056-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 26, 2025
|
Details |
|
SMV DSX New Line, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
|
FDA
Z-1044-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 10, 2025
|
Details |
|
SMV BodyTrack, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
|
FDA
Z-1046-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 10, 2025
|
Details |
|
Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHI
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
|
FDA
Z-1087-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 16, 2025
|
Details |
|
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
|
FDA
Z-1085-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 16, 2025
|
Details |
|
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
|
FDA
Z-1042-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 3, 2025
|
Details |
|
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
|
FDA
Z-1098-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 4, 2025
|
Details |
|
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
|
FDA
Z-1094-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 15, 2025
|
Details |
|
CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System
Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
|
FDA
Z-1099-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Oct 10, 2025
|
Details |
|
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Potential for microbial contamination.
|
FDA
Z-1095-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 11, 2025
|
Details |
|
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
|
FDA
Z-1083-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 9, 2025
|
Details |
|
Allura Xper FD20 Biplane; Model Number: 722008;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
|
FDA
Z-1067-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 15, 2025
|
Details |
|
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
|
FDA
Z-1021-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 24, 2025
|
Details |
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
|
FDA
Z-1059-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 26, 2025
|
Details |
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
|
FDA
Z-1060-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 26, 2025
|
Details |
|
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
|
FDA
Z-1038-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Oct 29, 2025
|
Details |
|
Portex Spinal Tray, Item No. A3729-24 A3595
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
|
FDA
Z-1101-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 19, 2025
|
Details |
|
Allura Xper FD10; Model Number: 722010;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
|
FDA
Z-1068-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 15, 2025
|
Details |
|
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
|
FDA
Z-1041-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 4, 2025
|
Details |
|
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
|
FDA
Z-1048-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 21, 2025
|
Details |
|
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
|
FDA
Z-1091-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 12, 2025
|
Details |
|
SMV DSI, System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
|
FDA
Z-1045-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 10, 2025
|
Details |
|
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
|
FDA
Z-1058-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Nov 26, 2025
|
Details |
|
Allura Xper FD20/10; Model Number: 722029;
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
|
FDA
Z-1076-2026
|
Medical Device | High |
Jan 21, 2026
Recall: Dec 15, 2025
|
Details |
Use brand, product name, UPC, lot code, best-by date, package size, allergen, contamination issue or distribution state.
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Use campaign results to understand the issue, then verify your VIN, car seat model or tire information with NHTSA or the manufacturer.
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If all affected details match, follow the official instructions. Keep packaging, take photos, save receipts and contact the company or retailer when a refund or repair is offered.
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