Medical Device Recalls Today
Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.
Search FDA medical device recalls and early alerts for equipment, software, implants, monitors, diagnostic tools and patient-use devices. Match device name, company, recall class, product code, UDI, model, lot and serial details.
Use this medical device recall search to check FDA device notices by device name, company, product code, lot number, recall class, risk level or correction/removal details.
| Product Recall | Source | Type | Risk | Date | Action |
|---|---|---|---|---|---|
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Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Potential for detachment of a distal tip component of the device during use.
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FDA
Z-1852-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 23, 2026
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Details |
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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
|
FDA
Z-1898-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 25, 2026
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Details |
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Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
Unapproved design changes to the products outside of the 510(k) clearance.
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FDA
Z-1879-2026
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Medical Device | High |
Apr 29, 2026
Recall: Feb 27, 2026
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Details |
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Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT SINUS PACK-LF DYNJ0101278F DYNJ0101278G DYNJ0101278I SINUS PACK DYNJ56262
Unapproved design changes to the products outside of the 510(k) clearance.
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FDA
Z-1880-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 27, 2026
|
Details |
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Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
|
FDA
Z-1940-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 18, 2026
|
Details |
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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
|
FDA
Z-1905-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 25, 2026
|
Details |
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Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1846-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
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Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML CONTROL W/ROTATOR, Model Number: DYNJSYR10CWR; 3) SYR CONTROL PAD 12ML L/L, Model Number: DYNJSYR12CP; 4) TBG PRESS 72IN M/F ROT BRAID, Model Number: DYNJBRT72R; 5) SYRINGE 10ML CONTROL MLL, Model Number: DYNJSYR10C; 6) SYRINGE 8ML CONTROL MLL, Model Number: DYNJSYR8C; 7) SYRINGE 12ML CONTROL MLL, Model Number: DYNJSYR12C; 8) SYR CONTROL PAD 10ML L/L ROT, Model Number: DYNJSYR10CRP; 9) SYR CONTROL PAD 12ML L/L ROT, Model Number: DYNJSYR12CRP; 10) CTRL SYRINGE 6ML RING ROT L/L, Model Number: DYNJSYR
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1831-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
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Details |
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Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK, Model Number: DYNJT5667; 7) WASTE MANAGEMENT KIT - 2, Model Number: DYNJWASTEKIT2; 8) CARDIAC CATH, Model Number: DYNJ20175J; 9) D&C PACK-POB, Model Number: DYNJ33521D; 10) BASIC PACK, Model Number: DYNJ38533F; 11) CATH PACK IMPLANT, Model Number: DYNJ39230D; 12) CERVICAL SPINE PACK, Model Number: DYNJ40886B; 13) MV-IR ANGIO DRAP
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1842-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
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OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
|
FDA
Z-1900-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 25, 2026
|
Details |
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Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECCUP, Model Number: DYNJ68902A 5) RADIOLOGY SPINE PACK, Model Number: DYNJ80679A 6) DR CHA CUSTOM PACK, Model Number: DYNJ82370A 7) SPINE PACK HC, Model Number: DYNJ84272
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1849-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
|
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Potential for detachment of a distal tip component of the device during use.
|
FDA
Z-1853-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 23, 2026
|
Details |
|
Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1850-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
|
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
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-1856-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 3, 2026
|
Details |
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Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
|
FDA
Z-1915-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 11, 2026
|
Details |
|
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
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-1870-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 3, 2026
|
Details |
|
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
|
FDA
Z-1932-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 9, 2026
|
Details |
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AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (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-1875-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 3, 2026
|
Details |
|
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Potential for product to contain foreign matter, confirmed to be inspect fragments.
|
FDA
Z-1896-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 25, 2026
|
Details |
|
Flamingo Funnel Medium, Model Number SQ20012-02
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
|
FDA
Z-1925-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 16, 2026
|
Details |
|
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
|
FDA
Z-1928-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 9, 2026
|
Details |
|
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
|
FDA
Z-1906-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 25, 2026
|
Details |
|
Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1840-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
|
Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PRESSURE OFF, Model Number: VASCSLPOFF1; 3) EP MANIFOLD KIT, Model Number: VASC1018A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
|
FDA
Z-1833-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Feb 25, 2026
|
Details |
|
LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
|
FDA
Z-1929-2026
|
Medical Device | High |
Apr 29, 2026
Recall: Mar 9, 2026
|
Details |
Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.
Use the device name, company, product code, UDI, model, catalog number, serial number, lot number, software version or implant card details.
Class I recalls are generally the most serious. Read the FDA notice for patient risk, affected devices, correction/removal steps and clinical action.
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.
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.
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.
Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.
Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.
Search the product name or brand, then compare model, serial, lot, code, date, retailer and official recall number details on the detail page.
Stop using the product if the official notice says to do so, keep the label or packaging, and follow the remedy instructions for repair, refund, replacement or disposal.
Recalls can be limited to certain production dates, factories, lots, model numbers, colors, sizes, retailers or distribution areas.
No. This page helps you search public recall data. Use the linked agency or company notice as the final source before taking action.