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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 821–840 of 1,000 recalls

Class IITerminated

Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile. (5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (9) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038301, UPN H965700383011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (10) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038303, UPN H96570038301, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (11) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039202, UPN H965700392021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (12) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039301, UPN H965700393011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; and (13) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70039303, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile.

Medline Industries Inc

Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180

ZOLL Circulation, Inc.

Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

August 6, 2021 · DeviceView details →

Class IITerminated

Soft Tissue Biopsy Needles

M.D.L. S.r.l.

Sterility assurance may be compromised.

August 5, 2021 · DeviceView details →

Class IITerminated

Mammary Nodules Localization

M.D.L. S.r.l.

Sterility assurance may be compromised.

August 5, 2021 · DeviceView details →

Class ITerminated

AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.

Armstrong Medical Services Limited

Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which could cause a delay in treatment. Not all defective canisters will be identified by the pre-use test.

August 5, 2021 · DeviceView details →

Class IITerminated

General Manual surgical instrument

M.D.L. S.r.l.

Sterility assurance may be compromised.

August 5, 2021 · DeviceView details →

Class IITerminated

Aspirated Cyto-Histological Biopsy needle

M.D.L. S.r.l.

Sterility assurance may be compromised.

August 5, 2021 · DeviceView details →

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