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.

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DateProductReasonClassFirm
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.