Browse Device Recalls

97 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 97 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 97 FDA device recalls.

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DateProductReasonClassFirm
Jun 19, 2020 EMPOWR Partial Knee Peg Drill; Model: 800-06-008. There have been issues experienced with the peg preparation steps, specifically drilling of the F... Class II Encore Medical, LP
Jun 19, 2020 EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. There have been issues experienced with the peg preparation steps, specifically drilling of the F... Class II Encore Medical, LP
Oct 22, 2019 EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026... The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking d... Class II Encore Medical, LP
Feb 4, 2019 EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument ... The firm has received reports/complaints concerning the breakage of the tips of the locking femo... Class II Encore Medical, Lp
Sep 21, 2018 Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset... Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting ... Class II Encore Medical, Lp
Sep 19, 2018 Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX... Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failur... Class II Encore Medical, Lp
Jul 10, 2018 djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S... The retaining ring on the neck trials has a potential to fail interoperatively. Class II Encore Medical, LP
Jun 26, 2018 Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP... A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide ... Class II Encore Medical, Lp
May 14, 2018 Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co... After receipt of a product complaint for the labeling, it was determined that this device does no... Class II Encore Medical, Lp
Jan 30, 2018 AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 8... Broken or missing screws and retaining clips. This may be due to screw tolerance and material st... Class II Encore Medical, Lp
Jan 29, 2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 8... It was discovered during a surgery that the design of the radius at the base of the pegs of the A... Class II Encore Medical, Lp
Jan 29, 2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 8... It was discovered during a surgery that the design of the radius at the base of the pegs of the A... Class II Encore Medical, Lp
Jan 29, 2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 8... It was discovered during a surgery that the design of the radius at the base of the pegs of the A... Class II Encore Medical, Lp
Jan 29, 2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 8... It was discovered during a surgery that the design of the radius at the base of the pegs of the A... Class II Encore Medical, Lp
Jan 29, 2018 Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 8... It was discovered during a surgery that the design of the radius at the base of the pegs of the A... Class II Encore Medical, Lp
Dec 12, 2017 EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Q... The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... Class II Encore Medical, Lp
Dec 12, 2017 EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE,... The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... Class II Encore Medical, Lp
Dec 12, 2017 DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qt... The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... Class II Encore Medical, Lp
Dec 12, 2017 EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Q... The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the impla... Class II Encore Medical, Lp
Sep 15, 2017 EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERIL... It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. Class II Encore Medical, Lp
Sep 15, 2017 EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE ... It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. Class II Encore Medical, Lp
Aug 4, 2017 MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numb... It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to ... Class II Encore Medical, Lp
Jun 26, 2017 Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
Jun 26, 2017 Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERIL... Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. Class II Encore Medical, Lp
May 31, 2017 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 0... Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... Class II Encore Medical, Lp
May 31, 2017 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01... Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibia... Class II Encore Medical, Lp
Feb 9, 2017 RSP Impaction Fixture During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... Class II Encore Medical, Lp
Feb 9, 2017 Turon Impaction Fixture During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from t... Class II Encore Medical, Lp
Jan 10, 2017 Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert a... The Empowr PS Insert was reported as missing the impaction slot feature. Class II Encore Medical, Lp
Jan 10, 2017 LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Mo... Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal ... Class II Encore Medical, Lp
Nov 15, 2016 Empowr Knee System Product Usage: Non-porous proximal tibial baseplate im... A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, ma... Class II Encore Medical, Lp
Sep 19, 2016 Empowr PS Knee System Box Cut Guide; Used to make the housing resection for ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Sep 19, 2016 Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Jul 26, 2016 Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... Class II Encore Medical, Lp
Jun 21, 2016 MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 a... Reported failure of the instrument. The retaining ring component of a neck trial became disassem... Class II Encore Medical, Lp
Dec 8, 2015 AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 C... The trial shell mating feature on the broach is undersized. Class II Encore Medical, Lp
Sep 16, 2015 Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For us... The labeling is missing the size/diameter information. Class II Encore Medical, Lp
Sep 15, 2015 AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba... Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ... Class II Encore Medical, Lp
Sep 14, 2015 Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon ... During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Imp... Class II Encore Medical, Lp
Sep 14, 2015 Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction ... During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form t... Class II Encore Medical, Lp
Jun 24, 2015 FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01... The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anteri... Class II Encore Medical, Lp
Apr 1, 2013 3DKnee e+ Tibial Insert. The insert is used along with the other components t... U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels... Class II Encore Medical, Lp
Sep 28, 2012 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac... A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea... Class II Encore Medical, Lp
Aug 9, 2012 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vi... The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The s... Class II Encore Medical, Lp
Jul 16, 2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t... One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ... Class II Encore Medical, Lp

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.