Browse Device Recalls
3,037 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,037 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 3,037 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research LLC |
| Nov 13, 2025 | FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 13, 2025 | SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000 | The items may have weak packaging seals that may result in a breach of sterility if the seal fail... | Class II | Medline Industries, LP |
| Nov 3, 2025 | SQ40S Blood Transfusion Filter | Due to products being released for distribution prior to completion of the required quality contr... | Class II | GVS TM, Inc |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number N... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medlin... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Me... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Numbe... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 27, 2025 | Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NO... | Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit... | Class II | Medline Industries, LP |
| Oct 8, 2025 | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... | Class II | Sterilmed, Inc. |
| Oct 8, 2025 | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... | Class II | Sterilmed, Inc. |
| Oct 6, 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
| Oct 6, 2025 | Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Produ... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
| Sep 30, 2025 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. | Potential for a weak seal in some units resulting in compromise in sterility. | Class II | Alcon Research LLC |
| Sep 23, 2025 | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klass... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | Total Joint Orthopedics, Inc. |
| Sep 9, 2025 | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Sep 9, 2025 | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | BioPro, Inc. |
| Aug 29, 2025 | NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalo... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Numbe... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 29, 2025 | NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number... | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. | Class II | Northeast Scientific Inc. |
| Aug 4, 2025 | Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Aug 4, 2025 | Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit. | Potential for open header bag seals, compromising sterility. | Class II | AVID Medical, Inc. |
| Jul 18, 2025 | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray M... | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Encore Medical, LP |
| Jul 17, 2025 | Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Mode... | Surgical drape packs may have open seals, which may compromise the sterility of the product. | Class II | O&M HALYARD INC |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jun 12, 2025 | Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Prepara... | The firm issued a field safety notice after becoming aware of three lots of products not having q... | Class II | Bridge to Life Ltd |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 10, 2025 | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VX... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect i... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
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.