Browse Device Recalls
740 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 740 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 740 FDA device recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. ... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. O... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthope... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthoped... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Mar 6, 2015 | CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Or... | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... | Class II | Wright Medical Technology, Inc. |
| Feb 9, 2015 | T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, ... | Incorrect labeling of the expiration date | Class II | MRP, LLC dba AMUSA |
| Feb 2, 2015 | EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMEN... | Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying... | Class II | Microport Orthopedics 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 |
| Nov 13, 2014 | Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biogra... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biog... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Bi... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biogra... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 13, 2014 | Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph m... | Possibility for system display freeze during CT interventional procedures. | Class II | Siemens Medical Solutions USA Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QT... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QT... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Nov 4, 2014 | LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, Q... | The stem taper on this device is undersized; the gauge point is not deep enough. | Class II | Smith & Nephew, Inc. |
| Aug 22, 2014 | DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, N... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Aug 22, 2014 | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc,... | These lots of suction canisters and lids have an insufficient seal under low or intermittent suct... | Class II | DeRoyal Industries Inc |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLA... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EAC... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONL... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 30, 2014 | CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY... | Plates manufactured from an incorrect raw material. | Class II | Wright Medical Technology, Inc. |
| Jul 2, 2014 | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERIL... | There was an error in manufacturing which resulted in the proximal lag screw hole being positione... | Class II | Smith & Nephew, Inc. |
| Jun 4, 2014 | DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by... | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... | Class II | DeRoyal Industries Inc |
| Jun 4, 2014 | DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: ... | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recall... | Class II | DeRoyal Industries Inc |
| Apr 30, 2014 | PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... | Difficulty removing the cup adaptor from the impaction handle during surgery | Class II | Microport Orthopedics INC. |
| Apr 4, 2014 | TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Apr 4, 2014 | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) RE... | A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Class II | Smith & Nephew Inc |
| Feb 21, 2014 | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product... | Moldy smell in product | Class II | DeRoyal Industries Inc |
| Jan 23, 2014 | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, ... | Inner spherical radius of the shell is undersized. | Class II | Smith & Nephew Inc |
| Jan 16, 2014 | DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Onl... | Three lots of circumcision clamps were manufactured out of specification and as a result may not ... | Class II | DeRoyal Industries 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 |
| Dec 5, 2013 | Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization ... | The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier. | Class II | Symmetry Medical/SSI |
| Nov 25, 2013 | REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-5... | One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing th... | Class II | Smith & Nephew Inc |
| Oct 7, 2013 | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. ... | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. | Class II | Smith & Nephew Inc |
| Oct 7, 2013 | GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188.... | Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. | Class II | Smith & Nephew Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, R... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Stra... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries Inc |
| Sep 17, 2013 | DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps N... | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to m... | Class II | DeRoyal Industries 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.