Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 13, 2017 | Fixed Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Central Venous Catheter Tray | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Whisker Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Left Atrial Catheter Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device insi... | Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch. | Class II | Ecolab, Inc. |
| Oct 13, 2017 | Double Flexible Tipped Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Reuter Tip Deflecting Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Femoral Artery Pressure Monitoring Set | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Bentson Cerebral Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Ultra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Amplatz Extra Stiff Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Movable Core Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 13, 2017 | Coons Interventional Wire Guide | Label does not state that the product is heparin-coated. | Class II | Cook Inc. |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgic... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 11, 2017 | Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manu... | The device may contain a manufacturing condition affecting the geometry of the driver's hex featu... | Class II | Zimmer Dental Inc |
| Oct 10, 2017 | MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8 | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHE... | Products labeled as sterile were distributed prior to sterilization | Class II | Medline Industries Inc |
| Oct 10, 2017 | STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (out... | The label outside the cardboard box is labeled correctly but the pouches inside of some of the bo... | Class II | Karl Storz Endoscopy |
| Oct 9, 2017 | Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Co... | Wrong device description of the label identifying the implant | Class II | Exactech, Inc. |
| Oct 6, 2017 | Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz... | The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a ... | Class II | CooperSurgical, Inc. |
| Oct 3, 2017 | Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is e... | HighPuragar was mislabeled and inadvertently sold as Noble Agar. | Class II | Becton Dickinson & Co. |
| Oct 3, 2017 | Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Num... | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue ... | Class III | Degania Silicone, Ltd. |
| Oct 3, 2017 | Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arth... | The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70... | Class II | Zimmer Biomet, Inc. |
| Oct 3, 2017 | iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR ... | Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UF... | Class II | Arthrex, Inc. |
| Oct 2, 2017 | AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the labe... | The system may duplicate sample requests leading to sample misidentification when connected to a ... | Class II | Beckman Coulter Inc. |
| Sep 30, 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is a... | Product was released to market without the adulteration strip included in the product. | Class III | Ameditech Inc |
| Sep 29, 2017 | Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Numb... | Knee implant components (tibial bearings) are labeled with the incorrect size. | Class II | Zimmer Biomet, Inc. |
| Sep 29, 2017 | NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 3.43 liter... | The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Sep 29, 2017 | Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, It... | Knee implant components (tibial bearings) are labeled with the incorrect size. | Class II | Zimmer Biomet, Inc. |
| Sep 25, 2017 | Regard Custom Surgical Pack Packs contain surgical instruments and accesso... | Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect l... | Class II | Resource Optimization & Innovation Llc |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 20, 2017 | Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Pe... | 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these ... | Class II | Merit Medical Systems, Inc. |
| Sep 20, 2017 | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog ... | 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. | Class II | Merit Medical Systems, Inc. |
| Sep 20, 2017 | Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Pe... | 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these ... | Class II | Merit Medical Systems, Inc. |
| Sep 20, 2017 | Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar... | Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do... | Class III | Philips Electronics North America Corporation |
| Sep 15, 2017 | EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERIL... | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | Class II | Encore Medical, Lp |
| Sep 15, 2017 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has b... | Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or i... | Class II | HILL-ROM MANUFACTURING, INC. |
| Sep 15, 2017 | EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE ... | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | Class II | Encore Medical, Lp |
| Sep 14, 2017 | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... | Class II | Cardiovascular Systems Inc |
| Sep 14, 2017 | Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy sys... | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... | Class II | Cardiovascular Systems Inc |
| Sep 13, 2017 | Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... | It was determined that the deflection length indicated on the Guide catheter handle does not matc... | Class II | Medtronic Vascular, Inc. |
| Sep 13, 2017 | SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 587... | The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The ... | Class II | The Metrix Company |
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.