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 |
|---|---|---|---|---|
| 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 |
| May 4, 2018 | remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH ... | Product may fail performance testing for S aureus ATCC 43300. | Class II | Thermo Fisher |
| May 2, 2018 | NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... | The bottles are mislabeled with an incorrect part number. | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| May 1, 2018 | Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... | The implants are mislabeled. | Class II | Keystone Dental Inc |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Ex... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 25, 2018 | Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Pro... | It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier ... | Class II | ConvaTec, Inc |
| Apr 25, 2018 | Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exa... | Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The i... | Class II | Baxter Healthcare Corporation |
| Apr 23, 2018 | DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4... | Non-sterile product was packaged inside a case that was labeled as sterile. | Class II | DeRoyal Industries Inc |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... | Complaints where users were unable to prime the administration set. | Class II | CareFusion 303, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 20, 2018 | LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code ... | Possible out of specification condition which may allow a bead component to separate from an adja... | Class II | Torax Medical, Inc. |
| Apr 16, 2018 | Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: P... | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm b... | Class II | Cook Inc. |
| Apr 16, 2018 | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 ... | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using compone... | Class II | Spinal Elements |
| Apr 13, 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... | The products are labeled with an incorrect product number. | Class II | Coltene Whaledent Inc |
| Apr 13, 2018 | Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Ca... | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. | Class II | St Jude Medical, Cardiac Rhythm Management Divi... |
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.