Browse Device Recalls

353 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 353 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 353 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 26, 2013	Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically fo...	Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds b...	Class II	Stryker Medical Division of Stryker Corporation
Nov 4, 2013	Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single u...	Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor...	Class II	Stryker Instruments Div. of Stryker Corporation
Nov 1, 2013	Acetabular Pressurizer; single use and six units per box. The Acetabular P...	On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer ...	Class II	Stryker Instruments Div. of Stryker 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 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 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
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
Feb 23, 2013	Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. How...	Stryker received reports from the field indicating that the handle detached from the cam of the B...	Class II	Stryker Howmedica Osteonics Corp.
Dec 18, 2012	Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg B...	Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2...	Class II	Stryker Medical Division of Stryker Corporation
Dec 18, 2012	Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg ...	Stryker Medical Model 3002S3EX and Model 3005S3EX beds built between March 15, 2012 and May 23, 2...	Class II	Stryker Medical Division of Stryker Corporation
Oct 11, 2012	The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system de...	Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have be...	Class II	Stryker Medical Division of Stryker Corporation
Jul 17, 2012	RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ...	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl...	Class II	Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012	RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable...	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 27, 2012	Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m...	Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t...	Class II	Stryker Medical Division of Stryker Corporation
Jun 27, 2012	Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m...	Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t...	Class II	Stryker Medical Division of Stryker Corporation
Jun 27, 2012	Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo...	Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t...	Class II	Stryker Medical Division of Stryker Corporation
Jun 27, 2012	Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo...	Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t...	Class II	Stryker Medical Division of Stryker Corporation
Jun 8, 2012	Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070...	Stryker has received two reports of serious injury as a result of tissue damage associated with t...	Class I	Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012	Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M...	Stryker has received two reports of serious injury as a result of tissue damage associated with t...	Class I	Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012	Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t...	Stryker has received two reports of serious injury as a result of tissue damage associated with t...	Class I	Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012	Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ...	Stryker has received two reports of serious injury as a result of tissue damage associated with t...	Class I	Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012	T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a...	The clear tape, that is intended to aid in the prevention of patients fluids from contacting the...	Class II	Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012	T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ...	The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ...	Class II	Stryker Instruments Div. of Stryker Corporation
May 17, 2012	Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both ...	An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G...	Class II	Stryker Medical Division of Stryker Corporation
May 17, 2012	Go Bed II+ Model FL28C Beds are intended for medical purposes in both gen...	An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G...	Class II	Stryker Medical Division of Stryker Corporation
May 17, 2012	Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in ...	An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G...	Class II	Stryker Medical Division of Stryker Corporation
May 17, 2012	Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in ...	An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G...	Class II	Stryker Medical Division of Stryker 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.