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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Date	Product	Reason	Class	Firm
Jun 14, 2016	Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687...	The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Va...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 13, 2016	Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 a...	potential contamination with potassium hydroxide may have an impact when performing immunohistoch...	Class II	Richard-Allan Scientific Company
Jun 8, 2016	Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (sy...	Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ...	Class II	Terumo Cardiovascular Systems Corporation
Jun 8, 2016	HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Managem...	Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ...	Class II	Terumo Cardiovascular Systems Corporation
Jun 8, 2016	Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-He...	Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ...	Class II	Terumo Cardiovascular Systems Corporation
Jun 8, 2016	Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a sour...	Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler ...	Class II	Terumo Cardiovascular Systems Corporation
May 5, 2016	Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Powe...	Complaints of smoke coming from the foot end of the cot. This reportedly occurred when either t...	Class II	Stryker Medical Division of Stryker Corporation
May 3, 2016	Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instru...	A patient specific case of Signature Personalized Patient Care System Knee Guides included a femu...	Class II	Materialise USA LLC
Apr 28, 2016	Maestro Air Motor Pneumatic cranial drill motor. The Maestro Air Pneumatic...	Due to the buildup of grease within the hose and motor, the product may require multiple attempts...	Class II	Stryker Instruments Div. of Stryker Corporation
Apr 22, 2016	Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sle...	Potential for a product defect where the cannula may be obstructed. This obstruction could preve...	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Apr 22, 2016	Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes	light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. ...	Class II	Acumedia Manufacturers, Inc.
Apr 6, 2016	EZ Slide Battery/line powered hydraulic table with removable leg section and ...	The potential exists within the identified tables that incorrectly manufactured parts have been u...	Class II	Skytron, Div. The KMW Group, Inc
Mar 28, 2016	Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, s...	Potential for the weld to fail at the pivot point of the monitor bracket. This weld failure coul...	Class II	Skytron, Div. The KMW Group, Inc
Mar 23, 2016	Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gel...	Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016....	Class III	Acumedia Manufacturers, Inc.
Mar 22, 2016	Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw ...	The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembl...	Class II	Stryker Instruments Div. of Stryker Corporation
Mar 21, 2016	SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model nu...	The affected scanner does not correctly interact with the SC360 software. When docked pre/postope...	Class II	Stryker Instruments Div. of Stryker Corporation
Mar 18, 2016	RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common ...	Multiple lots of the 26-FNLDRIVER, may have reduced mechanical strength, resulting in driver tip ...	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Mar 15, 2016	STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon ...	Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should...	Class II	Ventlab LLC
Mar 14, 2016	CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blo...	Specific CDI¿ Blood Parameter Monitoring System 500 devices are being voluntarily recalled becaus...	Class II	Terumo Cardiovascular Systems Corporation
Feb 16, 2016	Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For us...	Multiple complaints were received from customers indicating that they ordered product 8335(Type 3...	Class III	Richard-Allan Scientific Company
Feb 5, 2016	Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher	The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we...	Class II	Stryker Medical Division of Stryker Corporation
Feb 5, 2016	Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stret...	The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) we...	Class II	Stryker Medical Division of Stryker Corporation
Feb 4, 2016	50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit...	During an evaluation of the product packaging, it was determined that there is a potential for th...	Class II	Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016	50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user wit...	During an evaluation of the product packaging, it was determined that there is a potential for th...	Class II	Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016	(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with insert...	During an evaluation of the product packaging, it was determined that there is a potential for th...	Class II	Stryker Instruments Div. of Stryker Corporation
Feb 4, 2016	(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting...	During an evaluation of the product packaging, it was determined that there is a potential for th...	Class II	Stryker Instruments Div. of Stryker Corporation
Feb 2, 2016	S3 MedSurg Bed, Model 3005. Stryker Medical	CPU board failures cause fowler (backrest) electronic controls to stop working.	Class II	Stryker Medical Division of Stryker Corporation
Jan 19, 2016	Convenience Kits from Centurion that contain an In-Vision- Plus Needleless I...	Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being re...	Class II	Centurion Medical Products Corporation
Dec 3, 2015	Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressur...	Potential for power cord to melt; hazards include electric shock and fire.	Class II	Stryker Medical Division of Stryker Corporation
Dec 2, 2015	Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for di...	The hardware that holds the VESA plate and the display interface / monitor to the bracket may fai...	Class II	Skytron, Div. The KMW Group, Inc
Dec 1, 2015	PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy s...	Damage to package seals potentially compromising sterility.	Class II	JosNoe Medical, Inc.
Nov 30, 2015	Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is us...	Contamination of product with possible Bacillus spp	Class II	Acumedia Manufacturers, Inc.
Nov 23, 2015	Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units ...	The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date o...	Class II	Stryker Instruments Div. of Stryker Corporation
Oct 13, 2015	Two-stage and three-stage I.V. poles are shipped as an optional accessory to ...	It was identified by a customer complaint that some I.V. poles were retracting/lowering from an ...	Class II	Stryker Medical Division of Stryker Corporation
Sep 17, 2015	Disposable Paper Filter for Sterilization Containers Paper, Medical Access...	Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise ...	Class II	Stryker Craniomaxillofacial Division
Sep 11, 2015	Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ...	Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe...	Class III	Acumedia Manufacturers, Inc.
Aug 7, 2015	CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line moni...	Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a ...	Class II	Terumo Cardiovascular Systems Corporation
Jul 20, 2015	Neptune 2 Waste Management System Docking Station (120V and 230V), New and Re...	The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be ...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 2, 2015	Spirit One A-C Powered Hospital Bed	Inaccurate scale systems	Class II	Stryker Medical Division of Stryker Corporation
Jul 2, 2015	Spirit One A-C Powered Hospital Bed	Customer complaints associated with faulty brake system	Class II	Stryker Medical Division of Stryker Corporation
Jun 2, 2015	Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: ...	Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the p...	Class II	Stryker Instruments Div. of Stryker Corporation
May 29, 2015	Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Steril...	The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of imp...	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 22, 2015	0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (...	Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to compla...	Class II	Stryker Instruments Div. of Stryker Corporation
May 21, 2015	Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)0084...	Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored...	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 19, 2015	Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each...	A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in ...	Class II	Pointe Scientific, Inc.
May 15, 2015	MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bott...	Vial to vial variation in the fill volume that could affect control recovery issues and cause a c...	Class II	MedtestDx, Inc.
May 8, 2015	0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare...	Potential sterility breach in the packaging.	Class II	Stryker Instruments Div. of Stryker Corporation
May 4, 2015	Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103...	Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm becaus...	Class II	Stryker Instruments Div. of Stryker Corporation
May 1, 2015	100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Pe...	Terumo CVS is implementing field correction activities to address the identified causes of the Te...	Class II	Terumo Cardiovascular Systems Corporation
May 1, 2015	Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Pe...	Terumo CVS is implementing field correction activities to address the identified causes of the Te...	Class II	Terumo Cardiovascular Systems Corporation

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.