Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound recall — FDA Z-0180-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
26,155medical device recall records
2,290FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.759 records
Database records
Records — page 677
26,155 detailed records are currently available in this category.
Medical DeviceOct 30, 2019
Life Technologies Holdings Pte Torrent Suite Dx Software Version (IUO) 5.4 recall — FDA Z-0186-2020
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Class IIFDA: TerminatedLife Technologies Holdings Pte Ltd
Medical DeviceOct 30, 2019
Candela Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant recall — FDA Z-0208-2020
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Class IIFDA: TerminatedCandela Corporation
Medical DeviceOct 30, 2019
Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP recall — FDA Z-0161-2020
The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A,…
Class IIFDA: OngoingLuminex Molecular Diagnostics
Medical DeviceOct 30, 2019
Exactech Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the recall — FDA Z-0168-2020
Potential for the wire to fracture at the threads and remain in the glenoid.
Class IIFDA: TerminatedExactech, Inc.
Medical DeviceOct 30, 2019
Community Products Rifton E-Pacer, SKU K660, powered lift device recall — FDA Z-0166-2020
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Class IIFDA: TerminatedCommunity Products, LLC
Medical DeviceOct 30, 2019
ICU Medical Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # recall — FDA Z-0171-2020
A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show…
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 30, 2019
Beckman Coulter Lipase, REF OSR6130 and OSR6230 recall — FDA Z-0210-2020
NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceOct 30, 2019
Life Technologies Holdings Pte Torrent Suite Dx Software Version 5.6.4 recall — FDA Z-0187-2020
Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at…
Class IIFDA: TerminatedLife Technologies Holdings Pte Ltd
Medical DeviceOct 30, 2019
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698 recall — FDA Z-0211-2020
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceOct 30, 2019
GE Healthcare ApexPro Telemetry Server System recall — FDA Z-0175-2020
May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under…
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound recall — FDA Z-0184-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
Medical DeviceOct 30, 2019
Andover Healthcare Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound recall — FDA Z-0182-2020
Incomplete packaging seal of sterile product
Class IIFDA: TerminatedAndover Healthcare Inc.
Medical DeviceOct 30, 2019
Candela Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C recall — FDA Z-0209-2020
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize…
Class IIFDA: TerminatedCandela Corporation
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0127-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
Xodus Medical Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical recall — FDA Z-0149-2020
The sterile barrier of some devices may have been affected
Class IIFDA: TerminatedXodus Medical Inc.
Medical DeviceOct 23, 2019
Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation recall — FDA Z-0123-2020
Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
Class IIFDA: OngoingMedtronic Vascular Galway DBA Medtronic Ireland
Medical DeviceOct 23, 2019
Xodus Medical Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical recall — FDA Z-0150-2020
The sterile barrier of some devices may have been affected
Class IIFDA: TerminatedXodus Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0134-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0130-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0143-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0131-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0145-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
Medical DeviceOct 23, 2019
ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0146-2020
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Class IIFDA: TerminatedICU Medical Inc.
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.