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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

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DateProductReasonClassFirm
Apr 26, 2018 ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device i... When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately aft... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2017 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2017 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PEN... The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 13, 2014 ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), a... HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit p... Class II Horiba Instruments, Inc dba Horiba Medical
Aug 11, 2014 ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX P... Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability c... Class II Horiba Instruments, Inc dba Horiba Medical
Feb 14, 2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... Class II Horiba Instruments, Inc dba Horiba Medical
Jan 20, 2014 ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX... HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running t... Class II Horiba Instruments, Inc dba Horiba Medical
Dec 18, 2013 ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass... Class III Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2013 ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for ... Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a rev... Class II Horiba Instruments, Inc dba Horiba Medical
Sep 6, 2013 ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essentia... HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting ... Class III Horiba Instruments, Inc dba Horiba Medical
Mar 20, 2013 HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400IS... HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there a... Class II Horiba Instruments, Inc dba Horiba Medical
Feb 15, 2013 ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management ... Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrec... Class III Horiba Instruments, Inc dba Horiba Medical
Oct 10, 2012 PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully aut... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... Class II Horiba Instruments, Inc dba Horiba Medical
Oct 10, 2012 ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent i... Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation o... Class II Horiba Instruments, Inc dba Horiba Medical
Sep 20, 2012 ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTR... Class II Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012 ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot N... This recall was initiated because some customers were experiencing an alarm during Creatinine cal... Class III Horiba Instruments, Inc dba Horiba Medical
Sep 14, 2012 Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Leve... HORIBA Medical Irvine Technical Support received reports from some customers that have experience... Class III Horiba Instruments, Inc dba Horiba Medical

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.