Browse Device Recalls
184 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 184 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 184 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 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 24, 2011 | Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, con... | Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 24, 2011 | Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, co... | Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... | Class II | Stryker Instruments Div. 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.