APD Drain Manifold
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
All Recalls
95,018 total recalls in our database
SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Pain Tray Catalog Number: 9883
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Core Biopsy Tray Catalog Number: 8673R4
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
In-Line ventilator adaptor
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Procedural Accessory Kit Catalog Number: 9665R2
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Pump Refill Kit Catalog Number: 7347R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Joint Injection Tray Catalog Number: 8561R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Lumbar Tray Catalog 1091
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Universal Nerve Block Tray Catalog Number: 9818
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Nerve Block Tray Catalog Number: 3764R2
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Single Shot Epidural Tray Catalog Number: 6183R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
Locking Cap for PD Catheter Adapter
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Busse Hospital Disposables
🏥 Medical Devices Class I - Dangerous
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