Browse Device Recalls
2,115 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,115 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 2,115 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 23, 2018 | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for us... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with t... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intend... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 19, 2018 | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... | Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... | Class II | Teleflex Medical Europe Ltd |
| Mar 12, 2018 | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological mo... | Change Healthcare has identified an issue where, under certain circumstances, the Real Time Monit... | Class II | McKesson Israel Ltd. |
| Mar 12, 2018 | Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of ... | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labe... | Class II | Stryker GmbH |
| Mar 9, 2018 | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD.... | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the... | Class II | The Binding Site Group, Ltd. |
| Mar 2, 2018 | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI83... | Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instrume... | Class II | Randox Laboratories Ltd. |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 28, 2018 | Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)... | A potential commingle that could result in the product in the package not matching the product o... | Class II | Zimmer GmbH |
| Feb 27, 2018 | AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system i... | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may res... | Class II | Radiometer Medical ApS |
| Feb 23, 2018 | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is m... | There have been patient reports of abdominal hernia recurrence following hernia repair. The recal... | Class II | Sofradim Production |
| Feb 13, 2018 | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Au... | Module may freeze without generating user warning. There is a potential risk in delay of sample p... | Class II | Inpeco S.A. |
| Feb 5, 2018 | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualita... | Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... | Class II | Hyphen BioMed |
| Feb 5, 2018 | ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative scr... | Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... | Class II | Hyphen BioMed |
| Feb 5, 2018 | ZYMUTEST HIA MonoStria qualitative screening assay intended for the global de... | Incorrect package insert indicating use of the kits with plasma, serum, and other biological flui... | Class II | Hyphen BioMed |
| Feb 2, 2018 | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... | This recall has been identified due to the batch being mislabeled, with the packaged component's... | Class II | Signature Orthopedics Pty Limited |
| Jan 30, 2018 | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... | The firm received complaints regarding the incompatibility and dimensional interference between ... | Class II | Orthofix Srl |
| Jan 26, 2018 | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam f... | When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the t... | Class II | Ion Beam Applications S.A. |
| Jan 4, 2018 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended... | The low and high controls for the product are returning results above the assigned values. | Class II | The Binding Site Group, Ltd. |
| Jan 3, 2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... | Class II | ESAOTE S.P.A. |
| Jan 3, 2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, ... | The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... | Class II | ESAOTE S.P.A. |
| Dec 28, 2017 | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant ace... | Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is i... | Class II | IMPLANTCAST GMBH |
| Dec 14, 2017 | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar... | Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from ... | Class II | Abbott Gmbh & Co. KG |
| Dec 8, 2017 | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Acc... | Due to a system controller software anomaly, the patient positioning deviation correction may not... | Class II | Hitachi Ltd., Medical System Operations Group |
| Dec 4, 2017 | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following pr... | A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, a... | Class II | Cellavision AB |
| Dec 2, 2017 | Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software versi... | Fresenius Kabi initiated a mandatory software upgrade of the Volumat MC Agilia Volumetric Infusio... | Class II | Fresenius Vial Sa |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF ... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 27, 2017 | TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF T... | Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the... | Class II | SPINEART SA |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 24, 2017 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat... | UOC received a customer compliant report from our distributor on October 31, 2017 which stated t... | Class II | United Orthopedic Corporation |
| Nov 21, 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... | The device software versions have an anomaly which may produce an erroneous marking for the quali... | Class II | Oculus Optikgeraete GMBH |
| Nov 21, 2017 | Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z ... | It was discovered that the product units it imported may, at peak levels, emit radiation that ex... | Class II | SANTA JOY ORNAMENT & GIFTWARE CO |
| Nov 20, 2017 | Agility with Integrity R3.2 | Potential for positional errors following automatic table movement (ATM). | Class II | Elekta Limited |
| Nov 20, 2017 | Integrity R1.2 | Potential for positional errors following automatic table movement (ATM). | Class II | Elekta Limited |
| Nov 20, 2017 | Phadia Prime software, article number 12-4101-00, as used in combination with... | We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ... | Class II | Phadia Ab |
| Nov 20, 2017 | RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5,... | When calculating electron Monte Carlo dose with a very large number of histories, the dose calcul... | Class II | RAYSEARCH LABORATORIES AB |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product that include both f... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 16, 2017 | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLin... | Due to a human error at a supplier, an unknown number of devices within one specific production l... | Class II | Brainlab AG |
| Nov 10, 2017 | Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. | Internal program testing shows that product may not reach the indicated expiration date. | Class II | Wiener Laboratories |
| Nov 3, 2017 | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 462... | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly a... | Class II | Brainlab AG |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... | There is a potential for leaking vials for certain lot numbers where, if proper attire is not use... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Nov 2, 2017 | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 ... | The firm received reports of two breakages of the pin tips which occurred during two identical su... | Class II | Pro-Med Instruments Gmbh |
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.