Browse Device Recalls
10 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 10 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 10 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 24, 2016 | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND | Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC invol... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 24, 2016 | PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide... | Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalog... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 4, 2016 | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Sep 22, 2015 | Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... | Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| May 1, 2015 | Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... | Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Mar 30, 2015 | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gaug... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Nov 26, 2013 | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial... | Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Oct 28, 2013 | Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Numbe... | Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesi... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Sep 4, 2013 | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INS... | Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integr... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Jun 7, 2012 | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley Cit... | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadve... | Class III | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
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.