Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 4, 2019 | Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray ... | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the an... | Class II | Villa Sistemi Medicali S.P.A. |
| Oct 11, 2019 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... | Class II | AMD Medicom Inc. |
| Oct 11, 2019 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 ma... | Class II | AMD Medicom Inc. |
| Oct 9, 2019 | Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V A... | The firm has identified that packaging containing components of the hip replacement range are mi... | Class II | Signature Orthopaedics Europe Ltd |
| Oct 7, 2019 | Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI... | Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to... | Class II | The Binding Site Group, Ltd. |
| Oct 7, 2019 | NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545... | There is a remote potential for the sterile packaging of the transseptal guiding sheath to be com... | Class II | Baylis Medical Company Inc. |
| Oct 7, 2019 | TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-5... | There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath t... | Class II | Baylis Medical Company Inc. |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5052. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an ob... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an obser... | Class II | Randox Laboratories, Limited |
| Oct 4, 2019 | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. | Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an ob... | Class II | Randox Laboratories, Limited |
| Oct 2, 2019 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm ... | There is a potential for the screws to have become loosened during ultrasonic cleaning of the kno... | Class II | Pega Medical Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 660 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System | 905 nm laser diodes may be below rated power output. | Class III | Theralase Inc. |
| Sep 26, 2019 | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and I... | Class III | Theralase Inc. |
| Sep 23, 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and sh... | Class III | Randox Laboratories, Limited |
| Sep 16, 2019 | IceCure Cryoablation System ProSense -Intended for cryogenic destruction of t... | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical... | Class II | Icecure Medical Ltd |
| Sep 10, 2019 | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wo... | The instrument holder may be sent on a trajectory that is not within the intended target. If it i... | Class I | MEDTECH SAS |
| Sep 3, 2019 | Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Sep 3, 2019 | Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC150... | Medtronic has determined that some catheters have a slightly higher diameter stylette causing rem... | Class II | Medtronic Vascular Galway DBA Medtronic Ireland |
| Aug 26, 2019 | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-... | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... | Class II | LivaNova Deutschland GmbH |
| Aug 26, 2019 | Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15,... | The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used... | Class II | LivaNova Deutschland GmbH |
| Aug 21, 2019 | Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthop... | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the... | Class II | Zimmer GmbH |
| Aug 15, 2019 | Remisol Advance running on hardware with Windows XP, Windows 7, Windows Serve... | A patch was released for a critical remote code execution vulnerability in remote desktop service... | Class II | Normand-Info S.A.S.U. |
| Aug 14, 2019 | Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Pr... | The deficit displayed by the pump can differ from the real deficit, leading potentially to patien... | Class II | WOM World of Medicine AG |
| Aug 9, 2019 | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Aug 9, 2019 | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05... | The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1... | Class II | Randox Laboratories Ltd. |
| Aug 8, 2019 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx On... | The firm has become aware that there is a potential problem relating to the blood gas and immunoa... | Class II | Radiometer Medical ApS |
| Jul 30, 2019 | Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h | X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension o... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Jul 30, 2019 | RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indic... | Under certain conditions, a marble pattern infrequently appears on the monitor. | Class II | Eizo Corporation |
| Jul 30, 2019 | RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Produc... | Under certain conditions, a marble pattern infrequently appears on the monitor. | Class II | Eizo Corporation |
| Jul 29, 2019 | Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grai... | The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (B... | Class II | MOTEK MEDICAL B.V. |
| Jul 25, 2019 | Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF syst... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system i... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF s... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designe... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is des... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designe... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF syste... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is desi... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is desi... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 25, 2019 | Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed ... | The seal integrity of the sterile bag containing the kits may be compromised. | Class II | Stryker GmbH |
| Jul 19, 2019 | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs... | Class II | Coltene /Whaledent AG |
| Jul 18, 2019 | IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Li... | Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (... | Class II | Medical Intelligence Medizintechnik Gmbh |
| Jul 18, 2019 | Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, ... | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... | Class II | Thermo Fisher Scientific (Monterrey) |
| Jul 18, 2019 | Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen cont... | Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... | Class II | Thermo Fisher Scientific (Monterrey) |
| Jul 16, 2019 | MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.... | The firm received a complaint that the connector detached from the feeding tube. | Class II | Canadian Hospital Specialties |
| Jul 9, 2019 | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... | code 7-102 Liquid Sensor Error | Class II | Phadia Ab |
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.