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Browse Device Recalls

950 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 950 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 950 FDA device recalls in MI.

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DateProductReasonClassFirm
Apr 29, 2015 Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquef... Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... Class II Richard-Allan Scientific Company
Apr 29, 2015 Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Muco... Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a... Class II Richard-Allan Scientific Company
Apr 29, 2015 Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glov... Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufa... Class II Centurion Medical Products Corporation
Apr 24, 2015 EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLi... Potential for the device cannula to overthrow past the intended length. Class II Stryker Instruments Div. of Stryker Corporation
Apr 3, 2015 Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determin... Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in u... Class II Medtest Holdings, Inc.
Mar 26, 2015 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Troc... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main c... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 26, 2015 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... Class II Stryker Instruments Div. of Stryker Corporation
Mar 25, 2015 Universal Charger Product Usage: The Stryker Universal Battery Charg... The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... Class III Stryker Instruments Div. of Stryker Corporation
Mar 13, 2015 Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container ... Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen ... Class III Pointe Scientific, Inc.
Feb 19, 2015 Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon... The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as... Class III Richard-Allan Scientific Company
Feb 6, 2015 Terumo HX2 Temperature Management System provides temperature control of two ... Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby... Class II Terumo Cardiovascular Systems Corporation
Jan 7, 2015 System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ... Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h... Class II Stryker Instruments Div. of Stryker Corporation
Dec 22, 2014 Flyte Togas are components of the Stryker Flyte System and are intended to be... A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... Class III Stryker Instruments Div. of Stryker Corporation
Dec 17, 2014 MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) R... Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Ti... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot... Potential for implant damage, implant cracking off/breaking intra-operatively. Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implan... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Dec 17, 2014 MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, ... Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion... Class II Stryker Craniomaxillofacial Division
Dec 12, 2014 Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... Class III Pointe Scientific, Inc.
Nov 20, 2014 Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-0... During an investigation of instrument logs it was determined that In specific circumstances invol... Class II Phadia US Inc
Nov 11, 2014 ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 11, 2014 ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 11, 2014 ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 11, 2014 ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 11, 2014 ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For us... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Oct 23, 2014 Nerve Block Tray (Nerve Block convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC... MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values... Class III Medtest Holdings, Inc.
Oct 23, 2014 Diagnostic Imaging Tray (General Surgery convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 16, 2014 Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is... The box of guides for a specific case arrived intact but contained two (2) femoral guides instead... Class II Materialise USA LLC
Oct 8, 2014 Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The Sma... The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... Class II Stryker Instruments Div. of Stryker Corporation
Oct 8, 2014 Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The Sma... The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... Class II Stryker Instruments Div. of Stryker Corporation
Sep 30, 2014 Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Kn... Packaging of a device was compromised Class II Signal Medical Corporation
Sep 23, 2014 Microseal Augmented (20 degrees) Liner, acetabular liner component made from ... Incorrect dimension on four liners was detected Class II Signal Medical Corporation
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. 10% NBF is used t... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. Product Usage: 10... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company

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.