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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 661–680 of 1,000 recalls

Class IITerminated

Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

Ad-Tech Medical Instrument Corporation

Incorrect version of labels were used.

August 9, 2021 · DeviceView details →

Class IITerminated

Bivona Uncuffed Wire Endotracheal Tubes,

Smiths Medical ASD Inc.

Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.

August 9, 2021 · DeviceView details →

Class II

Terminated

Ad-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.

Ad-Tech Medical Instrument Corporation

Incorrect version of labels were used.

August 9, 2021 · DeviceView details →

Class IITerminated

ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312

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 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220

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 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107

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 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077

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

TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.

Johnson & Johnson Surgical Vision Inc

Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541

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 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213

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 8700-000871-40, Quattro (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 8700-000866-01, ICY 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: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3

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 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173

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 Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (10) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055003, UPN H965700550031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (11) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055008, UPN H965700550081, Three-way Stopcock with Rotating Adapter, Rx only, Sterile; (12) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055009, UPN H965700550091, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; and (13) NAMIC STOPCOCK, 1050 psi (72 bar), REF 70055017, UPN H965700550171, One-way Stopcock with Fixed Male Luer Lock, 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: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527

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

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

Intuitive Surgical, Inc.

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

August 6, 2021 · DeviceView details →

Class IITerminated

Zoll, REF 8700-000870-40, ICY (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 8700-000865-01, Cool Line 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: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305

ZOLL Circulation, Inc.

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

August 6, 2021 · DeviceView details →

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