Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2018 | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmi... | Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the ... | Class II | Beaver Visitec |
| Jun 15, 2018 | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the follow... | There is potential risk of brush detachment during cleaning. If brush detachment is not identifi... | Class II | Medline Industries Inc |
| Jun 12, 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep... | Incorrect use-by date on the device registration/patient file labels. | Class II | Inspire Medical Systems Inc. |
| Jun 11, 2018 | MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pedia... | The product may be packaged with the incorrect length of feeding tube as labeled. | Class II | Canadian Hospital Specialties |
| Jun 11, 2018 | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | Class II | Edwards Lifesciences, LLC |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 8, 2018 | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.0... | Class II | Stryker Neurovascular |
| Jun 6, 2018 | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol... | GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea... | Class II | GE Medical Systems, LLC |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III | Tosoh Bioscience Inc |
| Jun 4, 2018 | Leica Microsystems products labeled as the following: Leica M320 Microscope S... | Possible failure of screws which hold the gas spring fixation bracket in place. Due to this fail... | Class II | Leica Microsystems, Inc. |
| Jun 4, 2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... | Mislabeled product | Class III | Richard-Allan Scientific Company |
| Jun 4, 2018 | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is i... | The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorr... | Class II | CryoLife, Inc. |
| May 30, 2018 | FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... | Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... | Class II | Baxter Healthcare Corporation |
| May 29, 2018 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... | Cap may be mislabeled with incorrect part number, although the correct part number is on the main... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 24, 2018 | Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Discovery RT labeled as: a. MID BJG; b. HVY BJG | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 24, 2018 | Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers E... | Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is... | Class II | Zimmer Biomet, Inc. |
| May 24, 2018 | Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Dr... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Soft... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... | Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... | Class III | Beckman Coulter Inc. |
| May 24, 2018 | Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG ... | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be p... | Class II | GE Healthcare, LLC |
| May 23, 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr.... | Product contains dry natural rubber latex. Label states Latex Free. | Class II | Arrow International Inc |
| May 18, 2018 | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product C... | The Internal packaging, the pouch and patient labels are improperly labeled. | Class II | OMNIlife science Inc. |
| May 18, 2018 | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... | Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| May 18, 2018 | Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (s... | One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may le... | Class II | Zimmer Biomet, Inc. |
| May 18, 2018 | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and... | Potential for control line not appearing on the test strip | Class I | Qiagen Sciences, Inc. |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Produc... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To prov... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 17, 2018 | Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-... | Product pouch label may not easily identify the lot number, expiration date and associated symbo... | Class II | Arrow International Inc |
| May 16, 2018 | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Mode... | The solenoid plunger tip length is too short resulting in insufficient engagement to the Univers... | Class III | Becton, Dickinson and Company, BD Biosciences |
| May 15, 2018 | CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: ... | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered hig... | Class II | CAREstream Medical LLC |
| May 14, 2018 | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co... | After receipt of a product complaint for the labeling, it was determined that this device does no... | Class II | Encore Medical, Lp |
| May 11, 2018 | Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for u... | The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 si... | Class II | Zimmer Biomet, Inc. |
| May 11, 2018 | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) S... | The affected devices are manufactured to the same design specification as products intended for s... | Class II | Smith & Nephew, Inc. |
| May 11, 2018 | Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF... | The affected devices are manufactured to the same design specification as products intended for s... | Class II | Smith & Nephew, Inc. |
| May 10, 2018 | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, ... | Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct i... | Class II | Zimmer Dental Inc |
| May 9, 2018 | Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Produ... | There is a potential for a different set to be mixed within the lot, where the incorrect set does... | Class II | B. Braun Medical, Inc. |
| May 9, 2018 | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... | Class II | Johnson & Johnson Surgical Vision Inc |
| May 8, 2018 | AirLife Resuscitation Device, Pediatric labeled as the following: a. Ped... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
| May 8, 2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, ... | An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct... | Class I | Vyaire Medical |
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.