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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 341–360 of 1,000 recalls

Class IIOngoing

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252

Tornier, Inc

Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073

Cook Incorporated

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

March 5, 2026 · DeviceView details →

Class IIOngoing

Vue Motion V12. Product Number: 1017979.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

March 5, 2026 · DeviceView details →

Class IIOngoing

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

Koven Technology, Inc.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

March 4, 2026 · DeviceView details →

Class IIOngoing

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;

Angiodynamics, Inc.

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.

March 3, 2026 · DeviceView details →

Class IIOngoing

AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

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.

March 3, 2026 · DeviceView details →

Class IIOngoing

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

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.

March 3, 2026 · DeviceView details →

Class IIOngoing

Allura Xper FD20/15 OR Table; System Code: 722059;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

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.

March 3, 2026 · DeviceView details →

Class IIOngoing

Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

Wilson-Cook Medical Inc.

Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.

March 3, 2026 · DeviceView details →

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