Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0117-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0118-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0119-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0120-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0121-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0122-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA TUOHY 19GA SPRW OT.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0123-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions:
1. SESK PARKLAND MEMORIAL FX CSE TRAY.
2. SESK OWENSBORO DAVIESS HOSP 20058814.
3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID.
4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID.
5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL.
6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL.
7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL.
8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK.
9. SESK UAB SPINAL EPIDURAL.
10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL.
11. SESK, BSW SPINAL EPIDURAL TRAY.
12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0124-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0125-2026 Open, ClassifiedPosted Oct 9, 2025·Initiated Sep 18, 2025
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions:
1. CESK ROBERT WOOD JOHNSON UNIV HOSP.
2. CESK EAST JEFFERSON GEN HOSP 20071769.
3. CESK FLETCHER ALLEN HOSPITAL.
4. CESK WASHOE MEDICAL CENTER.
5. CESK DETROIT MEDICAL CTR 20064586.
6. CESK ALBANY MEDICAL CENTER.
7. CESK EPIDURAL BLOCK TRAY.
8. CESK, BSW EPIDURAL TRAY.
9. CESK HOWARD COUNTY GENERAL.
10. CESK CE17TKFC10L.
11. CESK WILLIAMSON MEDICAL CENTER.
12. CESK FLORIDA HOSPITAL.
13. CESK RIVERSIDE HEALTH SYSTEM.
14. CESK MAYO CLINIC OB.
15. CESK PRESBYTERIAN HOSPITAL DALLAS.
16. CESK HOUSTON METHODIST HOSPITAL.
17. CESK OHIO STATE UNIV MEDICAL CENTER.
18. CESK NORTONS WOMEN'S AND CHILDREN'S.
19. CESK BEN TAUB.
20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST.
21. CESK ALLEGHENY GENERAL HOSPITAL.
22. CESK UNIVERSITY OF ILLINOIS MED CTR.
23. CESK RUSH UNIVERSITY MEDICAL CENTER.
24. CESK ST. JOSEPH MEDICAL CENTER.
25. CESK INTEGRIS HEALTH.
26. CESK UMASS MEMORIAL.
27. CESK STANFORD UNIV HOSP 20054718.
28. CESK OVERLAKE HOSPITAL.
29. CESK CHRIST HOSPITAL 20057985.
30. CESK NEWTON-WELLESLEY HOSPITAL.
Reason: Potential for the lid of the catheter connector to be in the incorrect position.
Root cause: Process control
Recalling firm: B BRAUN MEDICAL INCType: Epidural Anesthesia KitDistribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.Recall #Z-0126-2026 CompletedPosted Oct 9, 2025·Initiated Aug 12, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I
The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US distribution to MA and RIRecall #Z-0127-2026
CompletedPosted Oct 9, 2025·Initiated Aug 12, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I
The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US distribution to MA and RIRecall #Z-0128-2026
CompletedPosted Oct 9, 2025·Initiated Aug 12, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I
The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US distribution to MA and RIRecall #Z-0129-2026
CompletedPosted Oct 9, 2025·Initiated Aug 12, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I
The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
Reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
Root cause: Process control
Recalling firm: Applied Medical Technology IncType: Tubes, Gastrointestinal (And Accessories)Distribution: US distribution to MA and RIRecall #Z-0130-2026
Open, ClassifiedPosted Oct 8, 2025·Initiated Sep 11, 2025
BD Alaris Pump Infusion Sets for the following reference numbers:
C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site
10015414, 180 Micron Filter
2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites
24201-0007, 2 SmartSite Y-sites
10012645, Back Check Valve, Non-vented, SmartSite Y-site
2426-0500, Back Check Valve, 3 SmartSite Y-sites
2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites
11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites
2410-0500, 2 SmartSite Y-Sites
2232-0007, 0.2 Micron Filter
11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites
10012144, 3 SmartSite Y-Sites, Check Valve
10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock
10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site
11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Set, Administration, IntravascularDistribution: US: Nationwide
OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore Taiwan, Province of China South AfricaRecall #Z-0035-2026
Open, ClassifiedPosted Oct 8, 2025·Initiated Sep 2, 2025
This device is a digital radiography/fluoroscopy system used in a diagnostic
and interventional angiography configuration. The system is indicated for use in diagnostic and
angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI,
covering the collimated area. If the customer changes the ROI, the collimator blades and static images
are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to
the default ROI position which may be larger than the specified one, leaving the X-ray area partially
covered by the static image. This is a software problem with the SPOT Fluoro program and will not
occur if the function is not used.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: Canon Medical System, USA, INC.Type: Interventional Fluoroscopic X-Ray SystemDistribution: U.S.Recall #Z-0037-2026
Open, ClassifiedPosted Oct 8, 2025·Initiated Sep 5, 2025
AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Reason: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.
Root cause: Software in the Use Environment
Recalling firm: GE Medical Systems, SCSType: System, Image Processing, RadiologicalDistribution: Domestic US distribution nationwide. International distribution worldwide.Recall #Z-0068-2026
Open, ClassifiedPosted Oct 8, 2025·Initiated Sep 3, 2025
SYNCHRON Systems Phosphorus (PHOSm) Reagent
REF: 467868
For In Vitro Diagnostic Use, Rx Only.
Reason: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Root cause: Unknown/Undetermined by firm
Recalling firm: Beckman Coulter Inc.Type: Phosphomolybdate (Colorimetric), Inorganic PhosphorusDistribution: US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV
OUS: Canada Mexico SingaporeRecall #Z-0071-2026
Open, ClassifiedPosted Oct 8, 2025·Initiated Aug 25, 2025
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M.
The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.
Reason: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Root cause: Process control
Recalling firm: LeMaitre Vascular, Inc.Type: Tissue Graft Of 6mm And GreaterDistribution: No US distribution. International distribution to Great Britian and Switzerland.Recall #Z-0072-2026
Open, ClassifiedPosted Oct 7, 2025·Initiated Sep 15, 2025
FDR Visionary Suite, CH-200
Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Reason: It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
Root cause: Device Design
Recalling firm: FUJIFILM Healthcare Americas CorporationType: System, X-Ray, StationaryDistribution: Domestic: AK, CA, FL, IL, MA, NH, OH, WI.Recall #Z-0044-2026