Browse Device Recalls
812 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 812 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 812 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the fo... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 12, 2023 | Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 | The scissors were manufactured without a tip protector resulting in the scissors breaking through... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 3, 2023 | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b)... | Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a st... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2023 | Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (... | The kits were damaged by water. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 28, 2023 | DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs | The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration da... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 2, 2023 | Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Ste... | The CirClamp subassembly found in the kit was the incorrect size. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 27, 2022 | (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per ca... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 27, 2022 | Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits p... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Dec 27, 2022 | (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD ... | The convenience trays had improper placement of some of the components that were in the nonsteril... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.