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
Oct 28, 2013	Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product cont...	Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber ba...	Class II	Centurion Medical Products Corporation
Oct 23, 2013	Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term car...	It was reported that the siderail may appear latched when it is not, due to lack of proper preven...	Class II	Stryker Medical Division of Stryker Corporation
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-rei...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. ...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gel...	Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm...	Class II	Terumo Cardiovascular Systems Corporation
Oct 23, 2013	Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r...	During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen...	Class II	Terumo Cardiovascular Systems Corporation
Oct 7, 2013	C-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm x 12...	As the result of a recent internal review of regulatory documents, we have determined that the 10...	Class II	RTI Surgical, Inc.
Oct 2, 2013	REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance Syste...	It was discovered that the silicone potting failed to properly cure after undergoing the prescrib...	Class II	Stryker Instruments Div. of Stryker Corporation
Aug 19, 2013	The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in el...	The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the openi...	Class II	Stryker Medical Division of Stryker Corporation
Jul 30, 2013	Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-439...	Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This coul...	Class II	Stryker Craniomaxillofacial Division
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1...	The operators manual does not fully describe the sequence of expected events that will occur when...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product ...	Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System ...	The operators manual does not fully describe the sequence of expected events that will occur when...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan...	TCVS is taking action to update the Operators Manual with the specific instructions to respond to...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V A...	Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1)...	Class II	Terumo Cardiovascular Systems Corporation
Jul 26, 2013	100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advan...	TCVS is taking action to update the Operators Manual with the specific instructions to respond to...	Class II	Terumo Cardiovascular Systems Corporation
Jul 18, 2013	Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late...	Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa...	Class II	Aspen Surgical Products, Inc.
Jul 12, 2013	IsoGel AIR 84, Support Surface. Intended to assist in improving human pati...	Complaints were received from the field indicating that some Air Pumps were flashing and alarming...	Class II	Stryker Medical Division of Stryker Corporation
Jul 1, 2013	Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performan...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013	CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used wit...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 1, 2013	RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and T...	The safety margin values detailed in the Engineering Design were entered incorrectly into the pro...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Pro...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product ...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 24, 2013	Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product...	A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet C...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 16, 2013	The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging ...	Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading informat...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 14, 2013	Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only...	The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.	Class II	PIONEER SURGICAL TECHNOLOGY, INC.
May 30, 2013	Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Co...	Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled hea...	Class II	Terumo Cardiovascular Systems Corporation
May 23, 2013	Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; si...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; sing...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO;...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; sin...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single ...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 23, 2013	Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us...	Based on an accelerated aging test for this product packaging, there is an indicator of potential...	Class II	Stryker Instruments Div. of Stryker Corporation
May 16, 2013	Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device wit...	Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick ...	Class II	The Standing Company
Apr 26, 2013	Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasi...	On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi...	Class II	Heart Sync, Inc
Apr 26, 2013	Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic ...	On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi...	Class II	Heart Sync, Inc
Feb 27, 2013	CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para...	Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software...	Class II	Terumo Cardiovascular Systems Corporation
Feb 27, 2013	CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood para...	Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software...	Class II	Terumo Cardiovascular Systems Corporation
Feb 27, 2013	CDI Blood Parameter Monitoring System 500 with Venous blood parameter module....	Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software...	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.