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 |
|---|---|---|---|---|
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292 | Cardinal Health recently received multiple complaints regarding various performance issues with C... | Class II | Cardinal Health 200, LLC |
| Dec 14, 2022 | GORE CARDIOFORM Septal Occluder, REF: GSX0030A | Septal Occluders released with incomplete quality test documentation that assesses the release of... | Class II | W L Gore & Associates, Inc. |
| Dec 13, 2022 | SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D) | A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-... | Class II | Olympus Corporation of the Americas |
| Dec 12, 2022 | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu... | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... | Class II | Steris Corporation |
| Dec 12, 2022 | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten... | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... | Class II | Steris Corporation |
| Dec 12, 2022 | BD Pyxis MedBank System - Product Label/labeling pending | Due to customer complaints related to the MedBank software which may indicate that a different me... | Class II | CareFusion 303, Inc. |
| Dec 12, 2022 | epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | Class II | Siemens Healthcare Diagnostics Inc |
| Dec 12, 2022 | DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic No... | Class II | DeRoyal Industries Inc |
| Dec 12, 2022 | epoc Host 2 as follows: Product SMN epoc Host 10736387 e... | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | Class II | Siemens Healthcare Diagnostics Inc |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N... | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... | Class II | Steris Corporation |
| Dec 12, 2022 | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte... | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s... | Class II | Steris Corporation |
| Dec 12, 2022 | cobas infinity central lab, Material Number 07154003001 | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 12, 2022 | Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... | An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... | Class II | Medtronic Perfusion Systems |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | Alinity m System. The Alinity m System is designed to automate the steps... | The firm identified the following three potential issues which may have impacted ADUs installed o... | Class II | Abbott Molecular, Inc. |
| Dec 9, 2022 | AXIOM Luminos Agile | There is potential for the footrest to detach from the patient table during use. | Class II | Siemens Medical Solutions USA, Inc |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24... | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or... | Class I | Smiths Medical ASD Inc. |
| Dec 9, 2022 | Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max | There is potential for the footrest to detach from the patient table during use. Device intend... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 8, 2022 | Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... | Potential for pilot balloon non-inflation or cuff non-deflation. | Class II | TELEFLEX LLC |
| Dec 8, 2022 | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of conta... | Class II | Medtronic Navigation, Inc. |
| Dec 8, 2022 | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended ... | Potential for pilot balloon non-inflation or cuff non-deflation. | Class II | TELEFLEX LLC |
| Dec 8, 2022 | Detect Covid-19 Test Product/Model Number: 21205 | There is an increased chance that the tests from affected lots may give false negative results. H... | Class II | Detect Headquarters |
| Dec 8, 2022 | Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... | Potential for pilot balloon non-inflation or cuff non-deflation. | Class II | TELEFLEX LLC |
| Dec 7, 2022 | Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Philips Garbin Ventilator, Model Number 1058180B | The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 dev... | Class I | Philips Respironics, Inc. |
| Dec 7, 2022 | IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMUL... | Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit l... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone i... | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... | Class II | The Anspach Effort, Inc. |
| Dec 7, 2022 | Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 7, 2022 | 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eM... | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... | Class II | The Anspach Effort, Inc. |
| Dec 7, 2022 | 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMa... | Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the at... | Class II | The Anspach Effort, 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.