Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 6, 2022 | Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT ... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRA... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B,... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 6, 2022 | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Numb... | Kits contain leaking bottles of isopropyl alcohol | Class II | MEDLINE INDUSTRIES, LP - SPT |
| Jun 3, 2022 | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE... | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. | Class II | Stryker Neurovascular |
| Jun 3, 2022 | SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numb... | The type of screw printed on the traceability record for the patient label is incorrect, but the ... | Class II | SAFE ORTHOPAEDICS LLC |
| Jun 3, 2022 | Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother. | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | Class II | ROi CPS LLC |
| Jun 3, 2022 | Hobbs Medical Polypectomy Snare, Catalog No. 7202 | During use, the sheath of the device may accordion at the proximal end where the sheath meets the... | Class II | Hobbs Medical, Inc. |
| Jun 3, 2022 | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part ... | Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. | Class II | ROi CPS LLC |
| Jun 3, 2022 | Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube place... | Firm has received complaints on the device concerning leak/rupture of either the bronchial or tra... | Class II | Ambu Inc. |
| Jun 2, 2022 | YelloPort Elite Universal Seal. For use in laparoscopic procedures. | There is the potential that YelloPort Elite Universal Seals packaging may contain small holes whi... | Class II | Surgical Innovations Ltd |
| Jun 2, 2022 | Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A | Under certain circumstances, the mounting screws may loosen or pull out from the attachment point... | Class II | Skytron, Div. The KMW Group, Inc |
| Jun 2, 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... | Class II | Breas Medical, Inc. |
| Jun 2, 2022 | Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT170... | As a result of unclear guidance in the service manual, the table can drop during a specific servi... | Class II | GE Healthcare, LLC |
| Jun 2, 2022 | DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System u... | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or D... | Class II | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. |
| Jun 2, 2022 | Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-... | The instrument is incorrectly color coded. | Class II | Wright Medical Technology, Inc. |
| Jun 1, 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause le... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 1, 2022 | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Sel... | SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin ... | Class II | Ultradent Products, Inc. |
| Jun 1, 2022 | RayStation 9B SP1. For radiation treatment planning. | An issue with propagation of treatment course information from RayStation with RayTreat to RayCar... | Class II | RAYSEARCH LABORATORIES AB |
| Jun 1, 2022 | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of... | Class II | Siemens Healthcare Diagnostics Inc |
| Jun 1, 2022 | Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle depende... | The LAS-100 Laser system may detect an inoperable hardware component during power up, which resul... | Class II | Spectranetics Corporation |
| Jun 1, 2022 | GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Ava... | There is a potential reversal of the O2 and air cylinder pressure transducer connections. | Class I | GE Healthcare, LLC |
| Jun 1, 2022 | Ventana HE 600 System, automated slide preparer, for use in laboratories. | There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in e... | Class II | Ventana Medical Systems Inc |
| May 31, 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not matc... | Class III | Boston Scientific Corporation |
| May 31, 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NaviCare Nurse Call/Voalte Nurse Call | An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, C... | Class II | Baxter Healthcare Corporation |
| May 31, 2022 | Xhibit Telemetry Receiver, Model: 96280 | Software related alarm escalation defect occurs after approximately 25 days of continuous use. Te... | Class II | Spacelabs Healthcare, Inc. |
| May 31, 2022 | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... | Firm has revised labeling to consistently call out storage conditions and revised the instruction... | Class III | Synapse Biomedical Inc |
| May 30, 2022 | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for chil... | Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring i... | Class II | Ossur Americas |
| May 30, 2022 | Positron Emission Tomography and Computed Tomography System, Model: uMI 550 | The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| May 27, 2022 | GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-... | The base of the anesthesia system can have a crack and could potentially fracture resulting in a ... | Class II | GE Healthcare, LLC |
| May 27, 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. | There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepanc... | Class II | Medtronic Neuromodulation |
| May 26, 2022 | SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150... | Device model and size for affected lots of Laser Fibers may be mismatched between the product's c... | Class II | Olympus Corporation of the Americas |
| May 26, 2022 | Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ E... | On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in th... | Class II | Ortho-Clinical Diagnostics, Inc. |
| May 26, 2022 | HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile) | Due to Titanium plasma coating not present implant. | Class II | Paragon 28, Inc. |
| May 25, 2022 | a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model N... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216 | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORME... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165 | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Cath... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Numb... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. TIDI PRODUCTS, LLC AquaGuard DRESSING, AQUA GUARD MOISTR 7X7 (5/PK) 9CENCO... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS ... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABS... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" C... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Len... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | a. DERMA SCIENCES, INC Surgitube BANDAGE, GAUZE SURGI WHT SZ15/8" 50YDS Catal... | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| May 25, 2022 | Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501 | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
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.