Medical DeviceDec 12, 2018
ASO Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT recall — FDA Z-0525-2019
Potential that gauze pads may not be fully sterilized
Class IIFDA: OngoingASO, LLC
26,628medical device recall records
2,311FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.778 records
Database records
Records — page 762
26,628 detailed records are currently available in this category.
Medical DeviceDec 12, 2018
Pfizer Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product recall — FDA Z-0554-2019
The firm received complaints of the wrap coming apart and leaking granular material
Class IIFDA: TerminatedPfizer Inc.
Medical DeviceDec 12, 2018
Barco N.V Optional MDRC-1119 Front Cover Attachment Kit for review display monitors recall — FDA Z-0527-2019
If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet…
Class IIFDA: TerminatedBarco N.V.
Medical DeviceDec 12, 2018
Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm recall — FDA Z-0542-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number recall — FDA Z-0536-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Philips Medical Systems (Cleveland) Brilliance 64, Model 728231 Product Usage: Computed recall — FDA Z-0543-2019
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceDec 12, 2018
STEPHANIX D2RS Digital Dynamic Remote recall — FDA Z-0557-2019
The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.
Class IIFDA: TerminatedStephanix
Medical DeviceDec 12, 2018
Tosoh Bioscience AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated recall — FDA Z-0559-2019
The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These labeling changes affect the Tosoh Quick Reference Guide, Training Manual and Training DVD…
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceDec 12, 2018
Siemens Medical Solutions USA Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego recall — FDA Z-0558-2019
This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube. The Artis zee system may lose coolant due to a possible leakage in a hose of the…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 12, 2018
Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item recall — FDA Z-0540-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm recall — FDA Z-0530-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Philips Medical Systems (Cleveland) Brilliance 10 Slice (Air), Model 728251 Product Usage recall — FDA Z-0547-2019
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceDec 12, 2018
Pfizer Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS recall — FDA Z-0556-2019
The firm received complaints of the wrap coming apart and leaking granular material
Class IIFDA: TerminatedPfizer Inc.
Medical DeviceDec 12, 2018
Philips Medical Systems (Cleveland) Brilliance 16 Slice (Air), Model 728246 Product Usage recall — FDA Z-0546-2019
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceDec 12, 2018
Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item recall — FDA Z-0538-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Zimmer ZMS Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm recall — FDA Z-0535-2019
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 12, 2018
Capintec Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 recall — FDA Z-0550-2019
There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its…
Class IIFDA: TerminatedCapintec Inc.
Medical DeviceDec 5, 2018
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B recall — FDA Z-0502-2019
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceDec 5, 2018
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis recall — FDA Z-0500-2019
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceDec 5, 2018
GE Healthcare Dash 5000 Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0521-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
Stryker Sustainability Solutions Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP recall — FDA Z-0498-2019
Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution…
Class IIFDA: TerminatedStryker Sustainability Solutions
Medical DeviceDec 5, 2018
GE Healthcare Solar 9500 Information Monitoring System is used to monitor physiologic recall — FDA Z-0524-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceDec 5, 2018
Siemens Healthcare Diagnostics Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent recall — FDA Z-0499-2019
Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceDec 5, 2018
GE Healthcare Solar 8000M Patient Monitoring System is used to monitor physiologic parameter recall — FDA Z-0523-2019
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
Class IIFDA: OngoingGE Healthcare, LLC
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.