Browse Device Recalls
126 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 126 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 126 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2017 | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Nov 3, 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Pac... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcath... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microca... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Jun 26, 2017 | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microca... | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured usin... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Card... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. ... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Oct 5, 2016 | Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Ca... | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conf... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M00... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M00354... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M00... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M00... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M00354... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M003542... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Jun 6, 2016 | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M00... | Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... | Class II | Stryker Neurovascular |
| Mar 21, 2016 | GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR... | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. | Class II | Stryker Neurovascular |
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.