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 |
|---|---|---|---|---|
| Dec 14, 2016 | 16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: ... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 14, 2016 | 14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medl... | Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possi... | Class II | MEDLINE INDUSTRIES INC |
| Dec 7, 2016 | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... | Damaged packaging, lack of sterility assurance | Class II | Medacta Usa Inc |
| Dec 2, 2016 | RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical... | Lack of sterility assurance | Class II | Biom'up |
| Nov 18, 2016 | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medica... | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | Class II | Teleflex Medical |
| Nov 8, 2016 | SWANSON FINGER JOINT #2, Part Number 4700002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number ... | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow On... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Ar... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnCon... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | INBONE STEM, TIBIAL, TOP, Part Number 200011901 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON FINGER JOINT #1, Part Number 4700001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow ... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Nov 8, 2016 | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufacture... | Sterility: Due to a potential incomplete seal on the outer sterile package. | Class II | Teleflex Medical |
| Oct 28, 2016 | SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. ... | Breach in sterile barrier compromising product sterility | Class II | Hologic, Inc |
| Oct 28, 2016 | Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 28, 2016 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pea... | The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate c... | Class II | Integra York PA, Inc |
| Oct 20, 2016 | Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number S... | The sterile packaging may contain small channels in the seal of the pouch, If the channels are p... | Class II | Micromedics, Inc. |
| Oct 14, 2016 | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, ... | Sterility of the outer surface of the container compromised due to packaging defect. | Class II | Covidien LLC |
| Oct 4, 2016 | Covidien Clearify Visualization System Item Code: 21-345 Intended to be us... | Product sterility is compromised due to breach of the sterile barrier | Class II | Medtronic |
| Oct 4, 2016 | Best Practices kits containing certain production lots of Clearify Visualizat... | Product sterility is compromised due to breach of the sterile barrier | Class II | Medtronic |
| Sep 20, 2016 | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... | Sterility of syringe product could not be assured. | Class II | Custom Medical Specialties, Inc. |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle i... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic ... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2m... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic S... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 16, 2016 | BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypode... | BD identified that several lots did not receive the specified dose of irradiation necessary to me... | Class II | Becton Dickinson & Company |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laprosc... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Sep 7, 2016 | Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Lapr... | Potential lack of assurance of sterility | Class II | Banyan Medical, LLC |
| Aug 11, 2016 | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 3, 2016 | BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe i... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available ... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adap... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 3, 2016 | BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, T... | Package Defect: Products may be at risk for having a slit defect on the package and that may affe... | Class II | C.R. Bard, Inc. |
| Aug 2, 2016 | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: T... | On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C ha... | Class I | Greatbatch Medical |
| Jul 29, 2016 | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start... | Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) ... | Class II | B. Braun Medical, Inc. |
| Jul 21, 2016 | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that conta... | Sterility seal integrity failures on the Renasys Sterile Transparent Film | Class II | Smith & Nephew, Inc. |
| Jul 19, 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used ... | Sterility compromised due to breach in sterile packaging | Class II | Smith & Nephew, Inc. |
| Jun 27, 2016 | CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 ... | The packaging seal may contain a crease. The crease may result in an open channel. These channel... | Class II | ConMed Corporation |
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.