Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) PLASTIC P... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... | As part of our post market surveillance, we recognized that some customers are using flammable fr... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Sep 3, 2024 | Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... | The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... | Class III | Trackx Technology Inc |
| Sep 1, 2024 | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label corre... | Class II | SIN SISTEMA DE IMPLANTE NACIONAL S.A |
| Aug 30, 2024 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instruct... | Class II | Stryker Neurovascular |
| Aug 28, 2024 | MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840 | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE HEART CABG CDS, REF CDS983376R | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART PACK, REF DYNJ66216C | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE OPEN HEART, REF DYNJ904261B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 28, 2024 | MEDLINE KIT CV I II, REF DYNJ906071B | Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Aug 27, 2024 | Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-3... | Incorrect expiration date. | Class II | Safeguard US Operating LLC |
| Aug 23, 2024 | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for ... | Class II | Stryker Spine |
| Aug 23, 2024 | Diode Laser Hair Removal model: WLA-01 | All model WLA-01 systems sold to US customers are found to have labeling non-compliances | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 23, 2024 | Non-ablative Fractional Laser Systems, Model: WFB-01 | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 un... | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 21, 2024 | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... | Class I | Percussionaire Corporation |
| Aug 13, 2024 | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 13, 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 12, 2024 | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) | 7F sheath introducers labeled as 7.5F | Class II | Merit Medical Systems, Inc. |
| Aug 12, 2024 | Seer Home System is an ambulatory electroencephalograph (EEG) system intended... | During CAPA investigations of sight production inconsistencies, it was highlighted that previous ... | Class II | SEER MEDICAL PTY LTD |
| Aug 12, 2024 | Custom Procedure Kit, REF: K12T-11077 | 7F sheath introducers labeled as 7.5F | Class II | Merit Medical Systems, Inc. |
| Aug 8, 2024 | Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use i... | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... | Class II | Zimmer GmbH |
| Aug 8, 2024 | eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal | On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals ... | Class III | T.G. Eakin Limited |
| Aug 8, 2024 | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, ... | Material with a quality issue was used in contact lens production, so contact lenses may not meet... | Class II | Alcon Research LLC |
| Aug 8, 2024 | Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in to... | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck ... | Class II | Zimmer GmbH |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.4 - 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 | Biodesign Fistula Plug C-FPS-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 | Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, Inc. |
| Aug 7, 2024 | Biodesign Fistula Plug C-FPS-0.2-2 - 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 Fistula Plug C-FPB-0.4 - 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 | Biodesign Fistula Plug C-FPS-0.4-2 - 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 Fistula Plug C-FPS-0.2 - 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 | Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce ... | Products expire prior to the expiration date printed on the product labeling | Class II | Cook Biotech, 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 | 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 | 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 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. |
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.