Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 851 - 875 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX18 The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.	FDA Z-1829-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 25, 2026	Details
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. Potential for detachment of a distal tip component of the device during use.	FDA Z-1854-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 23, 2026	Details
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK DYNJ69246B ABDOMINAL VASCULAR-LF DYNJ905291D ANGIOGRAPHIC PACK DYNJ86769 AORTAGRAM PACK DYNJ26783D AV FISTULA PACK CHS-LF DYNJ35615G AV SHUNT PACK-LF DYNJ0842516G CATHETER PACK DYNJ61926 EP DRAPE PACK-LF DYNJ47645C EP PACK DYNJ47782G EPS ACCESSORY PACK DYNJT2201S H CLINIC VASCULAR PK DYNJ33415A HEART FAILURE PACK DYNJ64877B HYBRID PACK DYNJ65925D INTERVENTIONAL RAD PACK DYNJ44100M INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AG MV-PACEMAKER PACK-LF DYNJ41556F NEURO RADIOLOGY RICHMOND DYNJ68365D OR HYB Unapproved design changes to the products outside of the 510(k) clearance.	FDA Z-1878-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 27, 2026	Details
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D Unapproved design changes to the products outside of the 510(k) clearance.	FDA Z-1885-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 27, 2026	Details
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.	FDA Z-1838-2026	Medical Device	High	Apr 29, 2026 Recall: Feb 25, 2026	Details
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches; The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	FDA Z-1862-2026	Medical Device	High	Apr 29, 2026 Recall: Mar 3, 2026	Details
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1799-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1802-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. Increased rate of out-of-specification endotoxin results.	FDA Z-1818-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. Increased rate of out-of-specification endotoxin results.	FDA Z-1817-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1803-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.	FDA Z-1810-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 12, 2026	Details
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. Increased rate of out-of-specification endotoxin results.	FDA Z-1819-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1800-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1798-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.	FDA Z-1824-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 16, 2026	Details
ARTIS Pheno VE30A and VE40A, Model 10849000 During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.	FDA Z-1814-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 12, 2026	Details
Philips Spectral CT on Rails. Model Number: 728334. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.	FDA Z-1825-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 7, 2026	Details
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.	FDA Z-1801-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. Increased rate of out-of-specification endotoxin results.	FDA Z-1816-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corn Due to a quality issue regarding the presence of burr on the finished cervical plate product.	FDA Z-1821-2026	Medical Device	High	Apr 22, 2026 Recall: Feb 20, 2026	Details
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.	FDA Z-1809-2026	Medical Device	High	Apr 22, 2026 Recall: Aug 13, 2025	Details
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data. Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.	FDA Z-1805-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 19, 2026	Details
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivati Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.	FDA Z-1822-2026	Medical Device	High	Apr 22, 2026 Recall: May 16, 2025	Details
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.	FDA Z-1812-2026	Medical Device	High	Apr 22, 2026 Recall: Mar 3, 2026	Details

Showing 851 - 875 of 1,678 product recalls

Prev 1 ... 33 34 35 36 37 ... 68 Next

Medical Device Recalls Today

Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.

Search The Device Label

Use the device name, company, product code, UDI, model, catalog number, serial number, lot number, software version or implant card details.

Recall Class And Risk Level

Class I recalls are generally the most serious. Read the FDA notice for patient risk, affected devices, correction/removal steps and clinical action.

What To Check On A Device Label

If the device supports or monitors health, do not stop treatment based only on a search result. Confirm with the official notice and your clinician when needed.

How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Match The Exact Medical device

Use each recall result to compare device name, company, product code, model, serial, lot number, UDI and software version. A similar name is not enough; recalls often apply only to specific versions or production ranges.

Read The Recall Hazard

Check the notice for FDA recall class, patient risk, correction, removal and clinical action. This helps you decide whether the item should be stopped immediately or handled through a normal remedy process.

Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.