Medical Device Recalls

Sterilmed, Inc.

Class II Ongoing

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Nu...

Reason: Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such a...

Z-0573-2026 November 26, 2025 Plymouth, MN

Olympus Corporation of the Americas

Class II Ongoing

Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: Th...

Reason: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All ...

Z-0572-2026 November 26, 2025 Center Valley, PA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0425-2026 November 12, 2025 Mansfield, MA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0423-2026 November 12, 2025 Mansfield, MA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0422-2026 November 12, 2025 Mansfield, MA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0426-2026 November 12, 2025 Mansfield, MA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0424-2026 November 12, 2025 Mansfield, MA

Mozarc Medical US LLC

Class II Ongoing

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

Reason: A potential issue with the seal integrity of header bag packaging.

Z-0421-2026 November 12, 2025 Mansfield, MA

BALT USA, LLC

Class I Ongoing

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The...

Reason: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

Z-0188-2026 November 5, 2025 Irvine, CA

MICROVENTION INC.

Class II Ongoing

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED401...

Reason: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly ap...

Z-0108-2026 October 22, 2025 Aliso Viejo, CA

Abbott

Class I Ongoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Z-0111-2026 October 22, 2025 Plymouth, MN

Abbott

Class I Ongoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Z-0112-2026 October 22, 2025 Plymouth, MN

Abbott

Class I Ongoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Z-0113-2026 October 22, 2025 Plymouth, MN

Abbott

Class I Ongoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Z-0109-2026 October 22, 2025 Plymouth, MN

Abbott

Class I Ongoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Z-0110-2026 October 22, 2025 Plymouth, MN

B BRAUN MEDICAL INC

Class II Ongoing

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 E...