Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-06-08FDA-DeviceBecton, Dickinson and Company, BD BiosciencesClass IIBD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in vitro identification of cells expressing the kappa light chains using flow cytometry.
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
- 2022-06-08FDA-DeviceAbbottClass IIFIRMap" Catheter, 60mm Basket
Incorrect product labeling.
- 2022-06-08FDA-DeviceXVIVO PERFUSION ABClass IIXVIVO Organ Chamber REF 19020
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
- 2022-06-08FDA-DeviceIntuitive Surgical, Inc.Class IIDAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
- 2022-06-08FDA-DeviceIntuitive Surgical, Inc.Class IIVESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
- 2022-06-08FDA-DeviceBio-Rad Laboratories, Inc.Class IIResin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CD¿ROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.
- 2022-06-08FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIThe C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The deflectable catheter is designed for placement of transvenous devices in or near the bundle of His. It features a deflecting distal section, controlled by the deflectable catheter handle,
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.
- 2022-06-08FDA-DeviceIon Beam Applications S.A.Class IIProteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM Pellet Insertion Tray Catalog Number: B9807
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class II3.2MM Pellet Insertion Tray Catalog Number: B9743
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IIMale SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IIFemale SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class II4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class II3.2MM Pellet Insertion Tray Catalog Number: B7345R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IIPellet Insertion Tray Catalog Number: B1654
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IIMale SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IIFemale SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class II4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class II4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
- 2022-06-08FDA-DeviceBusse Hospital Disposables, Inc.Class IISS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
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