Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus recall — FDA Z-1355-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
26,628medical device recall records
2,311FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.778 records
Database records
Records — page 735
26,628 detailed records are currently available in this category.
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile recall — FDA Z-1335-2019
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Compass Health Brands MediPress pneumatic compression system Full Arm (Medium)-Segmental recall — FDA Z-1345-2019
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class IIFDA: TerminatedCompass Health Brands (Corporate Office)
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile recall — FDA Z-1333-2019
Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH recall — FDA Z-1357-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage recall — FDA Z-1365-2019
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMay 22, 2019
Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a recall — FDA Z-1354-2019
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceMay 22, 2019
Siemens Medical Solutions USA Artis Zee recall — FDA Z-1339-2019
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A recall — FDA Z-1273-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP, SpO2, Rec, Product Number 863072 recall — FDA Z-1320-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP, Product Number 863069 recall — FDA Z-1317-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile recall — FDA Z-1331-2019
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Philips SureSigns VS4 NBP, SpO2, Product Number 863283 recall — FDA Z-1323-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon recall — FDA Z-1270-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 15, 2019
ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) recall — FDA Z-1304-2019
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Class IIFDA: TerminatedConmed Corporation
Medical DeviceMay 15, 2019
Ortho-Clinical Diagnostics VITROS 3600 Immunoassay System-Software V3.3.2 & below Product recall — FDA Z-1289-2019
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 15, 2019
Ortho-Clinical Diagnostics VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For recall — FDA Z-1292-2019
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 15, 2019
Cardinal Health 200 ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus recall — FDA Z-1283-2019
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceMay 15, 2019
Ortho-Clinical Diagnostics VITROS 5600 Integrated System -Software V3.3.2 & below Product recall — FDA Z-1287-2019
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 15, 2019
Zimmer Biomet T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet recall — FDA Z-1302-2019
There is a potential of fracture, bending or shearing of the driver.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 15, 2019
ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) recall — FDA Z-1305-2019
Voids in the seal or a partial seal results in an open channel and may compromise the sterility of the product
Class IIFDA: TerminatedConmed Corporation
Medical DeviceMay 15, 2019
Siemens Medical Solutions USA Cios Alpha with software version VA30-mobile C-arm x-ray recall — FDA Z-1295-2019
Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 15, 2019
Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry recall — FDA Z-1294-2019
Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
Class IIFDA: TerminatedMedica Corporation
Medical DeviceMay 15, 2019
Cardinal Health 200 ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product recall — FDA Z-1286-2019
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Class IIFDA: TerminatedCardinal Health 200, 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.