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Browse Device Recalls

51 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 51 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 51 FDA device recalls.

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DateProductReasonClassFirm
Feb 24, 2025 COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. Device is missing the pin in the graft loader component. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Feb 24, 2025 COR Disposable Kit, 8 mm. Cartilage Transplant System. Device is missing the pin in the graft loader component. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Ancho... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 4, 2019 Healix Knotless ADV BR 5.5 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 4, 2019 Healix Knotless ADV BR 4.75 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 30, 2018 Mitek Screw and Washer Depth Gauge, Product Code 219024 The device has an offset in the design that results in a reading approximately 3.2mm shorter than... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Dec 22, 2017 LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXP... Reports of product loosening or coming unscrewed from the handle. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 31, 2017 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set i... Leakage of FMS gravity tub sets (281113) at the bulb and tube connection Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 ... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 P... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product U... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Pro... Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operative... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 23, 2015 VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation b... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 29, 2013 DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Pro... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Aug 29, 2013 DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 ... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Apr 15, 2013 DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 10... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 16, 2012 DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DeP... Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labele... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Sep 6, 2012 SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cemen... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.

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.