Browse Device Recalls
81 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 81 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 81 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2017 | Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only | Medtronic has discovered the product lot in question was noted as having a longer drill tip exten... | Class II | Medtronic Sofamor Danek USA Inc |
| Dec 6, 2017 | Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF F... | Medtronic has discovered the directional arrow at the proximal end of the instrument may not corr... | Class II | Medtronic Sofamor Danek USA Inc |
| May 17, 2017 | KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R. | The directional arrow at the proximal end of the instrument may not correctly align with the cut... | Class II | Medtronic Sofamor Danek USA Inc |
| Apr 13, 2017 | Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE ... | Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles i... | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, MPCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, PS, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, CR, packaged in the following sizes and configurations:... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Feb 20, 2017 | Poly Component Trial, UCCS, packaged in the following sizes and configuration... | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, ... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee repl... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY:... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orth... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, ... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R,... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee repl... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 18, 2016 | TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orth... | The alpha total knee replacement components that may have not been passivated in accordance with ... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 13, 2015 | KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A,... | The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument... | Class II | Medtronic Sofamor Danek USA Inc |
| Dec 3, 2014 | POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic S... | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 6, 2014 | Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 3, 2014 | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Dane... | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 12, 2013 | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile ... | One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA,... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, ... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek US... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, I... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek ... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| May 28, 2013 | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, I... | Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resu... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 30, 2012 | ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 1... | Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 30, 2012 | PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 E... | Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... | Class II | Medtronic Sofamor Danek USA Inc |
| Aug 30, 2012 | ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-... | Lines on the screw gauge may not placed on the caddy properly which could result in improper meas... | Class II | Medtronic Sofamor Danek USA Inc |
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.