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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.

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DateProductReasonClassFirm
Nov 16, 2015 BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HE... The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birming... Class II Smith & Nephew, Inc.
Nov 9, 2015 Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUN... One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced... Class II Smith & Nephew, Inc.
Oct 20, 2015 Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT... The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar... Class II Smith & Nephew, Inc.
Oct 20, 2015 Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGH... The devices were packaged and laser marked anatomically incorrect. The Left plates were laser mar... Class II Smith & Nephew, Inc.
Oct 14, 2015 HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per bo... DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorr... Class II DeRoyal Industries Inc
Sep 10, 2015 DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7... These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drap... Class II DeRoyal Industries Inc
Aug 31, 2015 DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Sol... Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... Class II DeRoyal Industries Inc
Aug 31, 2015 DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (T... Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot... Class II DeRoyal Industries Inc
Aug 4, 2015 PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degr... Unexpected rate of postoperative fractures resulting in the need for revision surgery. Class I MicroPort Orthopedics, Inc.
Jul 21, 2015 CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008;... These screws have a potential of passing through the plate in the case when torque is applied in ... Class II Wright Medical Technology, Inc.
Jul 21, 2015 CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N300... These screws have a potential of passing through the plate in the case when torque is applied in ... Class II Wright Medical Technology, Inc.
Jul 14, 2015 Biograph mCT X-4R, Model Number 10248670 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT Flow Edge-4R, Model Number 10528955 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT S(40)-4R, Model Number 10248671 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph mCT S(64)-4R, Model Number 10248672 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 14, 2015 Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 Emission computed tomography systems and computed tomography xray systems with optional ceiling m... Class II Siemens Medical Solutions USA Inc.
Jul 2, 2015 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Ster... Procedures for the acceptance and control of in-process product have not been adequately establis... Class II MRP, LLC dba AMUSA
Jun 16, 2015 SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. ... Lack of sterility assurance. Class II Symmetry Surgical, Inc.
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF ... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx on... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
Apr 27, 2015 Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ... Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or... Class II DeRoyal Industries Inc
Apr 27, 2015 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, ... Incorrect expiration date on label Class II MRP, LLC dba AMUSA
Apr 22, 2015 Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrod... Incidence of breakage is higher than expected. Class II Vilex In Tennessee Inc
Apr 22, 2015 Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrod... Incidence of breakage is higher than expected. Class II Vilex In Tennessee Inc
Apr 22, 2015 Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrod... Incidence of breakage is higher than expected. Class II Vilex In Tennessee Inc
Apr 17, 2015 DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Produ... The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. Class II DeRoyal Industries Inc
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONT... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CO... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CON... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Apr 16, 2015 PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONT... The term DORSAL was laser etched on the incorrect side on some of the angled handles. Class II Wright Medical Technology, Inc.
Mar 6, 2015 CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. 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, 7-Hole, REF CCP-UTN7. 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, 2-Hole, REF CCP-UTN2. 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, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2... 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, Left, REF CCP-HSX1L. ... 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, NEUTRAL, Left, REF CCP-LPX0L.... 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, Right, REF CCP-LPX1... 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, Left, REF CCP-MPX1L. Orthopedi... 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, 2mm Step, Left, REF CCP-LPX2L... 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, NEUTRAL, Right, REF CCP-LPX0R... 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, Y-PLATE CX, REF CCP-YPX1. Orthopedic use. The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specific... Class II Wright Medical Technology, 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.