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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 341–360 of 1,000 recalls

Class IITerminated

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Procedure Tray Catalog 1065

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Universal Nerve Block Tray Catalog Number: 9779

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Single Shot Epidural Tray Catalog 1292

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

SS 4.5MM Pellet Insertion Tray Catalog Number: B9807

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Single Shot Epidural Tray - 18G Catalog Number: 8139R2

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Cervical Tray Catalog Number: 3765R2

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Epidural Tray Catalog 1307

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

CVC Dressing Change Kit Catalog Number: 2491R1

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

3.2MM Pellet Insertion Tray Catalog Number: B7345R1

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

MBB Tray Catalog Number: 9882

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Epidural Tray Catalog 1577

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Single Shot Epidural Tray Catalog 1165

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1

Busse Hospital Disposables, Inc.

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

February 22, 2022 · DeviceView details →
Class IITerminated

Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

SA3, LLC

Due to failure of microbial testing for total aerobic microbial count (TAMC).

February 21, 2022 · DeviceView details →
Class IITerminated

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

Freudenberg Medical, Llc

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

February 21, 2022 · DeviceView details →
Class IITerminated

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Freudenberg Medical, Llc

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

February 21, 2022 · DeviceView details →
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