Browse Device Recalls
26 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 26 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 26 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2022 | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with fram... | Class II | OrthoPediatrics Corp |
| Jun 29, 2022 | Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN | Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fract... | Class II | OrthoPediatrics Corp |
| Jul 6, 2020 | Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 S... | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have ... | Class II | OrthoPediatrics Corp |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Aug 19, 2019 | Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatr... | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i... | Class II | OrthoPediatrics Corp |
| Aug 19, 2019 | OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing P... | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a de... | Class II | OrthoPediatrics Corp |
| Aug 19, 2019 | Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pe... | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays i... | Class II | OrthoPediatrics Corp |
| Aug 3, 2017 | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage:... | The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on... | Class II | OrthoPediatrics Corp |
| Apr 24, 2017 | Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01... | Over-tensioning of the band resulting in damage to the band causing it to rupture | Class II | OrthoPediatrics Corp |
| Nov 18, 2016 | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical... | Labeled as a 48mm Cortical Screw but measuring at 50mm | Class III | OrthoPediatrics Corp |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Jul 27, 2016 | 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLo... | OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compressio... | Class II | OrthoPediatrics Corp |
| Nov 10, 2015 | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5... | Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured in... | Class II | OrthoPediatrics Corp |
| Jul 28, 2015 | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part nu... | The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a d... | Class II | OrthoPediatrics Corp |
| Jul 25, 2014 | ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9... | Weld fractures on the Sleeve Installation Tool for ACL reconstruction system. | Class II | OrthoPediatrics Corp |
| Jan 8, 2014 | 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No.... | OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical ... | Class II | OrthoPediatrics Corp |
| Nov 7, 2013 | OrthoPediatrics ACL Reconstruction System is a pediatric and small stature ad... | Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - Nov... | Class II | OrthoPediatrics Corp |
| Sep 26, 2013 | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke... | Class II | OrthoPediatrics Corp |
| Jul 24, 2013 | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System ... | OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #913... | Class II | OrthoPediatrics Corp |
| Apr 19, 2013 | 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage:... | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... | Class II | OrthoPediatrics Corp |
| Apr 19, 2013 | 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage:... | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... | Class II | OrthoPediatrics Corp |
| Apr 19, 2013 | 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage:... | Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have... | Class II | OrthoPediatrics Corp |
| Oct 18, 2012 | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, ext... | Complaint received from sales representative that the drill guide tubes would not screw into repl... | Class II | OrthoPediatrics Corp |
| Sep 13, 2012 | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary... | A complaint received from sales representative that a replenishment instrument was too short. Upo... | Class II | OrthoPediatrics Corp |
| Jun 14, 2012 | OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... | The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. | Class II | OrthoPediatrics Corp |
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.