Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2017 | ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume I... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-428... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 22, 2017 | (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) ... | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... | Class II | Arrow International Inc |
| Dec 11, 2017 | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels p... | Product sterility potentially compromised. | Class II | Medical Action Industries Inc |
| Nov 9, 2017 | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)45... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. ... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)45465400394... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Pre... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)761325250... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)76132... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UD... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: ... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 9, 2017 | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 060... | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 6, 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Pro... | Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... | Class II | Owen Mumford USA, Inc. |
| Nov 6, 2017 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Pro... | Device may potentially be compromised by water in end user packaging. Exposure to liquid may comp... | Class II | Owen Mumford USA, Inc. |
| Nov 3, 2017 | ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Nov 3, 2017 | NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... | Contact lenses lack sterility assurance. | Class II | Alden Optical |
| Oct 23, 2017 | Surgical punch; sealed pouches packed in punch shelf box Intended for use... | Surgical punches are being recalled due to potential packaging damage which may have occurred dur... | Class II | Alto Development Corp |
| Oct 23, 2017 | Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pou... | Possible open seal on top portion of the package. Could cause breach of sterility. | Class II | Medline Industries Inc |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx O... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Oct 20, 2017 | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat tr... | Potential breach of sterility of the packaging. | Class II | Shippert Medical Technologies |
| Oct 20, 2017 | HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice... | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, ... | Class II | Terumo BCT, Inc. |
| Sep 18, 2017 | MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERIL... | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead... | Class II | MicroPort Orthopedics Inc. |
| Sep 11, 2017 | BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and syn... | Cut resistant surgical glove liners lack sterility assurance. | Class II | Zimmer Biomet, Inc. |
| Sep 5, 2017 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class II | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 550 ml Sterile¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 15 ml Normal Saline ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
| Sep 5, 2017 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | Class I | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medi... |
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.