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 |
|---|---|---|---|---|
| Apr 8, 2019 | Drill, cannulated, 4x120mm, AO, Item Number ST502015402 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 3x90mm, round shaft, Item Number 502015630 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.8x150mm, AO, Item Number 502015629 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 2.5x95mm, AO, Item Number 502015621 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | CBS micro, countersink, cannulated, round-shaft, Item Number 503004341 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, cannulated, 3x90mm, AO, Item Number ST502015631 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | Drill, contra-angle, 1.5x85mm, Item Number ST502015706 | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 8, 2019 | V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 50... | An investigation identified that the products were possibly manufactured from a different materia... | Class II | Zimmer GmbH |
| Apr 5, 2019 | Alinity i Processing Module, 03R65 01, with the below components. a. TED (... | Potential loose cable connections on the reagent cooler, which could result in temperature errors... | Class II | Abbott Gmbh & Co. KG |
| Apr 3, 2019 | DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR T... | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFi... | Class II | Delfi Medical Innovations, Inc. |
| Apr 3, 2019 | Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance... | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or othe... | Class II | Elekta Limited |
| Apr 3, 2019 | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Pro... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| Apr 3, 2019 | Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff... | Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFi... | Class II | Delfi Medical Innovations, Inc. |
| Apr 3, 2019 | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article ... | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become ... | Class II | Thommen Medical AG |
| Apr 3, 2019 | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Produc... | The target values and ranges in these lots are incorrect. | Class II | Randox Laboratories Ltd. |
| Mar 25, 2019 | Horizon Cardiology Hemo | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... | Class II | Change Healthcare Israel Ltd. |
| Mar 25, 2019 | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energiza... | Magnet Energization Device (MED) can have a residual voltage on output terminal, may cause electr... | Class II | Philips Medical Systems Nederlands |
| Mar 25, 2019 | McKesson Cardiology Hemo | users are not notified of procedure medication discrepancies between the Vitals and Meds, the Pro... | Class II | Change Healthcare Israel Ltd. |
| Mar 15, 2019 | Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re... | There is an error in the chromomap included in the labeling for the product. | Class III | Cytocell Ltd. |
| Mar 12, 2019 | Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta... | Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The... | Class II | Elekta Limited |
| Mar 11, 2019 | RT Elements Software revisions of the RT Elements applications have a speci... | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements softw... | Class II | Brainlab AG |
| Mar 11, 2019 | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 | Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liqui... | Class II | Randox Laboratories Ltd. |
| Feb 27, 2019 | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software ... | In certain occurrences, the affected navigation software application might unexpectedly display a... | Class I | Brainlab AG |
| Feb 26, 2019 | Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i... | The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... | Class II | Abbott Gmbh & Co. KG |
| Feb 26, 2019 | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c... | The safety interlock covering the septum piercing probes within the bulk solution bottle holder m... | Class II | Abbott Gmbh & Co. KG |
| Feb 22, 2019 | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitativ... | Reports have been received of lower MS2 MFI values when using the panel. | Class II | Luminex Molecular Diagnostics |
| Feb 19, 2019 | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C ... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... | Class II | Philips Medical Systems Nederlands |
| Feb 19, 2019 | Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Prot... | Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits | Class II | The Binding Site Group, Ltd. |
| Feb 19, 2019 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Produ... | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitc... | Class II | Philips Medical Systems Nederlands |
| Feb 13, 2019 | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality ... | An error in the assignment of the control range pH in Blood Gas Control | Class II | Randox Laboratories Ltd. |
| Feb 7, 2019 | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usag... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Feb 7, 2019 | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: ... | The target value for uptake is incorrect on the value sheet for an analyzer. The target value fo... | Class III | Randox Laboratories Ltd. |
| Jan 30, 2019 | Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TS... | The vertical dimensions of screw-hole position in some standalone cages might be out of range in ... | Class II | U&I CORP. |
| Jan 25, 2019 | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, ... | Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibi... | Class III | Agfa N.V. |
| Jan 21, 2019 | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage... | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instr... | Class II | Stryker GmbH |
| Jan 11, 2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Su... | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel b... | Class II | AAP Implantate Ag |
| Jan 10, 2019 | 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is ... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 10, 2019 | 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended ex... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclu... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG con... | Class II | PerkinElmer Life and Analytical Sciences, Walla... |
| Jan 7, 2019 | AVE 2 Birthing Bed | LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by ... | Class II | Linet Spol. S.r.o. |
| Dec 28, 2018 | 16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Produc... | The firm had a report of doctors being unable to pull the obstetric forceps apart. | Class II | Fetzer Medical GmbH & Co. KG |
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.