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FDA Recalls
›Device Recalls

FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 221–240 of 1,000 recalls

Class IITerminated

MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

Baxter Healthcare Corporation

Devices distributed lacked regulatory clearance.

February 25, 2022 · DeviceView details →

Class IITerminated

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

Baxter Healthcare Corporation

Product is mislabeled as self-righting Luer slip tip caps, yellow.

February 25, 2022 · DeviceView details →

Class II

Terminated

(a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #88-9808; and (d) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Wolf Scope, Catalog #88-9809.

Carefusion 2200 Inc

The finished device package did not contain the IFU.

February 23, 2022 · DeviceView details →

Class IITerminated

3.2MM Pellet Insertion Tray Catalog Number: B9743

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

Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568

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

Nerve Block Tray Catalog Number: 8415

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 Number: 8417

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 DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560

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:B8128R1

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

Pain Tray Catalog Number: 9883

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

Core Biopsy Tray Catalog Number: 8673R4

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 DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559

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

Procedural Accessory Kit Catalog Number: 9665R2

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

Pump Refill Kit Catalog Number: 7347R1

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

Joint Injection Tray Catalog Number: 8561R1

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

Lumbar Tray Catalog 1091

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: 9818

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

Nerve Block Tray Catalog Number: 3764R2

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 Number: 6183R1

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

4.5 MM Pellet Insertion Tray Catalog Number: B8121R1

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 →

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