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 |
|---|---|---|---|---|
| Nov 8, 2016 | SWANSON TRAPEZIUM IMPLANT, Part Number 4520002 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | INBONE STEM, TIBIAL, TOP, Part Number 200011901 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | SWANSON FINGER JOINT #1, Part Number 4700001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 8, 2016 | PRO-STIM 10cc INJECTABLE, Part Number 86SR0410 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Class II | Wright Medical Technology, Inc. |
| Nov 7, 2016 | PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only,... | DeRoyal received complaints of mold on Tennis Elbow Straps. | Class II | DeRoyal Industries Inc |
| Nov 7, 2016 | TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Onl... | DeRoyal received complaints of mold on Tennis Elbow Straps. | Class II | DeRoyal Industries Inc |
| Aug 29, 2016 | TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038,... | Some Bipolar shells were manufactured with an out of specification retainer groove. | Class II | Smith & Nephew, Inc. |
| Aug 29, 2016 | TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 7132... | Some Bipolar shells were manufactured with an out of specification retainer groove. | Class II | Smith & Nephew, Inc. |
| Aug 11, 2016 | DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surg... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries Inc |
| Aug 11, 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom s... | The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe ... | Class II | DeRoyal Industries 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 |
| Jul 6, 2016 | SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1),... | The labels correctly state that the product should be a 25mm screw, but the box contained a longe... | Class II | Smith & Nephew, Inc. |
| Jun 30, 2016 | PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intend... | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212... | Class II | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF ... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, R... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF P... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF ... | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modula... | Class III | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| Jun 21, 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA... | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate ... | Class I | MicroPort Orthopedics Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 714... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 714... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 7142... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 7142... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| May 26, 2016 | LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 714213... | The surface inside of the femoral component, where cement is applied for adhesion, is below speci... | Class II | Smith & Nephew, Inc. |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions USA Inc. |
| Apr 25, 2016 | BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siem... | The bracket that is used to lift the cover has bolts that were not welded in potentially causing ... | Class II | Siemens Medical Solutions 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.