Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 7, 2024 | Cath Lab Pack, CECL02P; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Paracentesis Thoracente, SLPT76H; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissu... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Neuro Vascular, ANKV91A; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | PACEMAKER PACK, SLCV01J; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Nasal Sinus Pack, MTSN26B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | IR Procedure Pack, CEAT19W; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Stryker has identified an issue with the characterization process that impacted the constant valu... | Class II | Howmedica Osteonics Corp. |
| Aug 7, 2024 | Vaginal Delivery, ASDV25B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Hand Pack, AKHD97C; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in th... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Pacemaker, COPM11B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 6, 2024 | General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog ... | The syringes that were inadvertently shipped from the Distribution Center. This product was on qu... | Class II | Cypress Medical Products LLC |
| Aug 6, 2024 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventio... | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 Set AU; Product Code: 1000361; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 371 14F LT CMR Set; Product Code: 0048-0045; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, EU; Product Code: 0048-0014; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years inste... | Class II | MICROVENTION INC. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 381 Pump Set (US); Product Code: 1000080; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging proces... | GE HealthCare has become aware of an issue where image storage is not possible when Centricity PA... | Class II | GE Healthcare |
| Aug 5, 2024 | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set; Product Code: 1000402; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device ... | Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product... | Class II | QUANTUM SURGICAL SAS |
| Aug 5, 2024 | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs ... | A patient specific, custom-made device was supplied for a surgical procedure that did not match t... | Class II | Howmedica Osteonics Corp. |
| Aug 5, 2024 | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 2, 2024 | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Cata... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Aug 2, 2024 | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN161... | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result... | Class II | Bard Peripheral Vascular Inc |
| Aug 2, 2024 | Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p... | Class II | AURIS HEALTH INC |
| Aug 2, 2024 | Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Mode... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Aug 2, 2024 | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch ... | Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower p... | Class II | AURIS HEALTH INC |
| Aug 2, 2024 | Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Re... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Aug 1, 2024 | AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
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.