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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 301–320 of 1,000 recalls

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 →
Class IITerminated

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.

Deerfield Imaging, Inc.

Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.

February 17, 2022 · DeviceView details →
Class IITerminated

LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS

Kaneka America Corp

Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.

February 17, 2022 · DeviceView details →
Class IITerminated

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

Wright Medical Technology, Inc.

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

February 15, 2022 · DeviceView details →
Class IITerminated

Compella Therapy Air Supply Unit

Baxter Healthcare Corporation

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

February 14, 2022 · DeviceView details →
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