Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 22, 2021 | Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex... | Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed... | Class II | Baxter Healthcare Corporation |
| Jul 21, 2021 | STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... | Class II | Cardiovascular Systems Inc |
| Jul 21, 2021 | MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0... | There is a potential that a package sheath contains an incorrect dilator. | Class II | Merit Medical Systems, Inc. |
| Jul 21, 2021 | Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use"... | There is a potential that sample carriers (w or w/o samples) within automated sampling system ma... | Class II | Beckman Coulter Inc. |
| Jul 21, 2021 | CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-... | Device failed to function as intended and/or failed to conform to their design specifications. | Class II | Trophy SAS |
| Jul 21, 2021 | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter,... | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are bein... | Class I | Cordis Corporation |
| Jul 21, 2021 | MPR Slotted Mallet, labeling etched onto devices as follows: Medical Prod... | Potential for mallet head to become separated from mallet handle. There is also significant defo... | Class II | Implant Resource Inc |
| Jul 20, 2021 | Solero Generator PG, Item No. H78712740000, Catalog No. 12740000 | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | Solero Generator Refurbished PG, Item No. H78712740000D0, Catalog No. 12740000D | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisi... | An internal component may be cracked and become lodged behind the energy button potentially resul... | Class II | Ethicon Endo-Surgery Inc |
| Jul 20, 2021 | FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: ... | Due to product complaints received for false negative results (dropouts) with blood culture ident... | Class II | BioFire Diagnostics, LLC |
| Jul 20, 2021 | Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent meas... | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dr... | Class II | Welch Allyn Inc |
| Jul 20, 2021 | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12... | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 20, 2021 | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisio... | An internal component may be cracked and become lodged behind the energy button potentially resul... | Class II | Ethicon Endo-Surgery Inc |
| Jul 20, 2021 | CritiCool, thermoregulation device | Premature pump failure may lead to the device displaying a HALT 4 error, from which the device ca... | Class II | Belmont Instrument Corporation |
| Jul 20, 2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 008436851... | Potential defective gas inlet pressure regulator within ventilator which could result in gas rel... | Class II | NIHON KOHDEN ORANGEMED, INC |
| Jul 20, 2021 | Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US | Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to ... | Class II | Angiodynamics, Inc. |
| Jul 19, 2021 | Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X | The balloon protective sheath may potentially be contaminated with a foreign material left over f... | Class II | Cordis Corporation |
| Jul 16, 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 Y... | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy... | Class II | Philips North America LLC |
| Jul 16, 2021 | RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, RE... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 15, 2021 | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... | Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... | Class III | Cell Marque Corporation |
| Jul 15, 2021 | (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Prod... | The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magne... | Class II | Philips North America |
| Jul 15, 2021 | Pneupac paraPac plus 300 ventilator kit, REF P300NGB | Two devices were labeled with the same serial number | Class III | Smiths Medical ASD Inc. |
| Jul 15, 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017... | There is a potential that the data management system may add additional cells to the patient requ... | Class II | Beckman Coulter Inc. |
| Jul 14, 2021 | FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA | Angioplasty system has a manufacturing issue that has the potential to result in difficulty defla... | Class II | Ostial Corporation |
| Jul 14, 2021 | smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use duri... | The nail head may become detached during surgery. | Class II | Smith & Nephew Orthopaedics Ltd. (Aurora) |
| Jul 14, 2021 | Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ... | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ... | Class II | Maquet Medical Systems USA |
| Jul 14, 2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrum... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... | Class II | Pentax of America Inc |
| Jul 14, 2021 | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-27... | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (E... | Class II | Pentax of America Inc |
| Jul 13, 2021 | Pipeline Flex Embolization Device | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 13, 2021 | EV3 Pipeline Flex Embolization Device with Flex Shield Technology | Due to potential push wire fractures in the delivery system during use. The issue presents as a ... | Class I | Micro Therapeutics Inc, |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | ACUSON Juniper Diagnostic Ultrasound System | Due to intermittent failures of the power supply in the ultrasound system which renders it inoper... | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 12, 2021 | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXX... | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub du... | Class II | W. L. Gore & Associates Inc. |
| Jul 12, 2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... | Deterioration in the stability of the reagents which has resulted in lower than expected or out o... | Class III | Stanbio Laboratory, LP |
| Jul 12, 2021 | Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... | A design defect (hardware and software) allows liquid waste pressure to build up and potentially ... | Class II | Abbott Laboratories, Inc |
| Jul 9, 2021 | EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombo... | EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance | Class II | Ortho8, Inc. |
| Jul 9, 2021 | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Num... | There is a potential for internal leaks within catheters. | Class II | Edwards Lifesciences, LLC |
| Jul 9, 2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABE... | Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece,... | Class II | PROCEPT BIOROBOTICS CORPORATION |
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.