Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 22, 2022 | I.V. Start Kit Catalog 8172 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Port Tray Catalog 7607 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Sterile Epidural Tray Catalog Number: 6259R2 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP... | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevate... | Class II | Instrumentation Laboratory |
| Feb 22, 2022 | "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Single Shot Epidural Tray Catalog Number: 6183R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Numb... | Incorrect tibial base plate implant packaged in kit | Class II | Conformis, Inc. |
| Feb 22, 2022 | Nerve Block Tray Catalog Number: 3764R2 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog numbe... | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient sa... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 22, 2022 | Universal Nerve Block Tray Catalog Number: 9818 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Lumbar Tray Catalog 1091 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Joint Injection Tray Catalog Number: 8561R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Pump Refill Kit Catalog Number: 7347R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Procedural Accessory Kit Catalog Number: 9665R2 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Core Biopsy Tray Catalog Number: 8673R4 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Pain Tray Catalog Number: 9883 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Single Shot Epidural Tray Catalog Number: 8417 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Nerve Block Tray Catalog Number: 8415 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 22, 2022 | 3.2MM Pellet Insertion Tray Catalog Number: B9743 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professi... | Class II | Busse Hospital Disposables, Inc. |
| Feb 21, 2022 | Liko Universal Twinbar 670 QRH, an accessory that can be used together with m... | An incorrect center bolt was used in the assembly of the product which could result in a patient ... | Class II | Baxter Healthcare Corporation |
| Feb 21, 2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... | Class II | Freudenberg Medical, Llc |
| Feb 21, 2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782... | Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Emboli... | Class II | Freudenberg Medical, Llc |
| Feb 21, 2022 | Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm | Due to failure of microbial testing for total aerobic microbial count (TAMC). | Class II | SA3, LLC |
| Feb 19, 2022 | Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene su... | Transport company failed to stop at the border for required FDA inspection. | Class II | Ansell Healthcare Products LLC |
| Feb 18, 2022 | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems ... | Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used i... | Class II | NeuMoDx Molecular Inc |
| Feb 18, 2022 | Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood ... | Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of th... | Class II | Maquet Medical Systems USA |
| Feb 18, 2022 | ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OC... | Evaporation of stabilizing liquid reducing shelf life. | Class II | DNA Genotek Inc. |
| Feb 18, 2022 | 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile... | There is potential for the images to be flipped left to right. | Class II | GE Healthcare, LLC |
| Feb 18, 2022 | ORAcollect RNA: ORE-100 | Evaporation of stabilizing liquid reducing shelf life. | Class II | DNA Genotek Inc. |
| Feb 18, 2022 | Medical Device products purchased from Family Dollar retail stores located in... | Potential exposure to rodents and rodent activity in the distribution center. | Class II | Dollar Tree Distribution, Inc. |
| Feb 18, 2022 | 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II | GE Healthcare, LLC |
| Feb 18, 2022 | SIGNA Excite 3T. Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II | GE Healthcare, LLC |
| Feb 18, 2022 | Signa 1.5T TwinSpeed Magnetic Resonance Imaging System | There is potential for the images to be flipped left to right. | Class II | GE Healthcare, LLC |
| Feb 17, 2022 | LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, produc... | Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients ... | Class II | Kaneka America Corp |
| Feb 17, 2022 | Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a co... | Reports have been received that after normal or routine lateral forces are applied to the head fi... | Class II | Deerfield Imaging, Inc. |
| Feb 16, 2022 | Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 1... | IRISpec CA failures for glucose. | Class III | Beckman Coulter, Inc. |
| Feb 15, 2022 | Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 520... | An incorrect screw is packaged in the product, which contains a locking screw instead of a non-lo... | Class II | Wright Medical Technology, Inc. |
| Feb 15, 2022 | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for... | When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range... | Class II | Ion Beam Applications S.A. |
| Feb 15, 2022 | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small su... | Class II | Luminex Corporation |
| Feb 15, 2022 | Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in c... | The photomultiplier tube, may have compromised functionality in some instruments. As a result, th... | Class II | Meridian Bioscience Inc |
| Feb 14, 2022 | Compella Bariatric Bed System | Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... | Class II | Baxter Healthcare Corporation |
| Feb 14, 2022 | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... | Class III | Cook Medical Incorporated |
| Feb 14, 2022 | BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [It... | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... | Class II | Biomet, Inc. |
| Feb 14, 2022 | Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ve... | Cybersecurity Improvement Action-not equipped against potential cyber security threats | Class II | Draeger Medical, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.