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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 601–620 of 1,000 recalls

Class IITerminated

OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009

B. Braun Medical, Inc.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

August 10, 2021 · DeviceView details →
Class IITerminated

Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400

B. Braun Medical, Inc.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

August 10, 2021 · DeviceView details →
Class IITerminated

TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917

DePuy Orthopaedics, Inc.

Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

August 10, 2021 · DeviceView details →
Class IITerminated

TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420916

DePuy Orthopaedics, Inc.

Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

August 10, 2021 · DeviceView details →
Class IITerminated

TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578

DePuy Orthopaedics, Inc.

Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.

August 10, 2021 · DeviceView details →
Class IITerminated

OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361

B. Braun Medical, Inc.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

August 10, 2021 · DeviceView details →
Class IITerminated

Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214

B. Braun Medical, Inc.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

August 10, 2021 · DeviceView details →
Class IITerminated

Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413

B. Braun Medical, Inc.

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

August 10, 2021 · DeviceView details →
Class IITerminated

Ad-Tech Lightweight 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

Bivona Aire-Cuf Endotracheal Tube

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 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 IITerminated

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 →
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