Browse Device Recalls
3,179 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,179 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 3,179 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 | 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 |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 12, 2023 | Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 400... | The product contains an expired diluent vial. If the impacted product is used, the sterility of t... | Class II | TELEFLEX LLC |
| Apr 6, 2023 | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for... | Inadvertently released for distibution without sterility assurance. | Class II | Cardinal Health 200, LLC |
| Mar 28, 2023 | YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 28, 2023 | YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR | Optical Trocars sterility assurance can not be guaranteed | Class II | Surgical Innovations Ltd |
| Mar 10, 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... | Sterility; Steril surgical procedure packs contain incomplete seals. | Class II | Alcon Research, LLC |
| Feb 13, 2023 | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS ... | Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. ... | Class II | Maquet Medical Systems USA |
| Jan 30, 2023 | CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog ... | Product did not meet shelf-life testing requirements resulting in a breach of the sterility of th... | Class II | Carefusion 2200 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.