Browse Device Recalls
4,602 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 4,602 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 4,602 FDA device recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 19, 2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System... | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specific... | Class II | Biointellisense Inc. |
| Jul 19, 2024 | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... | Class I | Inari Medical - Oak Canyon |
| Jul 17, 2024 | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-123... | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system che... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 12, 2024 | Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... | Due to mislabeling of products | Class II | Meddev Corp |
| Jul 12, 2024 | Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog ... | Due to mislabeling of products | Class II | Meddev Corp |
| Jul 12, 2024 | Ion Endoluminal System, REF: 380748-65 | There is a potential that the robotic system's instrument cart arm may contain screws that may ... | Class II | Intuitive Surgical, Inc. |
| Jul 9, 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 9, 2024 | BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jul 1, 2024 | Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. | Class II | Neurovision Medical Products Inc |
| Jun 25, 2024 | HeartMate 3 System Controllers provided within the following HeartMate 3 Left... | Left ventricular assist system controller UI membrane/screen may lift along the edge of the contr... | Class II | Thoratec LLC |
| Jun 25, 2024 | Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... | Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... | Class II | Preat Corp |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software versio... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version ... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software ver... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 24, 2024 | BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software ve... | Due to software issue, there is a potential when a restock label is printed for a medication stor... | Class II | CareFusion 303, Inc. |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370 | Specimen collection device may leak after the patient sample swabs have been inserted into the te... | Class II | Cepheid |
| Jun 14, 2024 | Alinity hq Analyzer, REF: 09P68-01 | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... | Class II | Abbott Laboratories |
| Jun 7, 2024 | OMTech Desktop Laser Engraver | Lack of redundant interlocks, missing required labels and certification labels as required by 21 ... | Class II | Rygel Advanced Machines d/b/a Omtech Laser |
| Jun 4, 2024 | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/... | Insufficient weld around the cap component of the instrument is insufficient to withstand impact... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| Jun 3, 2024 | Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve... | Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of t... | Class II | Nalu Medical, Inc. |
| May 27, 2024 | Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Sof... | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... | Class II | Hitachi America, Ltd., Particle Therapy Division |
| May 27, 2024 | Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 | LIH Influence check settings for Lipemia are incorrect which may result patient samples being rep... | Class II | Beckman Coulter Inc. |
| May 27, 2024 | Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Soft... | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... | Class II | Hitachi America, Ltd., Particle Therapy Division |
| May 27, 2024 | Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Sof... | During positioning within the system's 3D to 3D matching mode while transferring CBCT images, whe... | Class II | Hitachi America, Ltd., Particle Therapy Division |
| May 24, 2024 | Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COV... | Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Autho... | Class II | CUE HEALTH INC |
| May 21, 2024 | BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units | Due to a software issue the PC unit may not connect to the server which could impact wireless dat... | Class II | CareFusion 303, Inc. |
| May 17, 2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| May 17, 2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm ... | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone... | Class II | SEASPINE ORTHOPEDICS CORPORATION |
| May 13, 2024 | BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN ... | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... | Class II | CareFusion 303, Inc. |
| May 13, 2024 | BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH ME... | Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have n... | Class II | CareFusion 303, Inc. |
| May 10, 2024 | MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-... | The terminal block used to secure the power supply cable for the gradient coil of the MRI system ... | Class II | Canon Medical System, USA, INC. |
| May 8, 2024 | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... | System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... | Class I | Thoratec Corp. |
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.