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Browse Device Recalls

155 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 155 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 155 FDA device recalls.

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DateProductReasonClassFirm
Jan 6, 2017 DePuy Synthes various orthopedic instruments modified by U.S. Distributors ... Products were made outside of Quality System Regulation, and potentially outside of premarket sub... Class II DePuy Orthopaedics, Inc.
Nov 8, 2016 LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Inser... DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision Syste... Class II DePuy Orthopaedics, Inc.
Oct 25, 2016 ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non... DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due... Class II Depuy Orthopaedics Inc.
Jan 8, 2016 SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an optio... Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. Thi... Class II DePuy Orthopaedics, Inc.
Sep 8, 2015 Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The S... DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Int... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: T... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surf... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation S... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articul... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Art... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Mar 4, 2015 LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prost... The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... Class II DePuy Orthopaedics, Inc.
Mar 4, 2015 LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthop... The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... Class II DePuy Orthopaedics, Inc.
Feb 23, 2015 RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instru... This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery... Class II DePuy Orthopaedics, Inc.
Feb 11, 2015 SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl m... One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in sur... Class II DePuy Orthopaedics, Inc.
Nov 12, 2014 I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. ... Use of excessive force when impacting may lead to intra-operative femoral fracture. Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors a... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in ... Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during i... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Imp... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 10, 2014 Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactor... ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... Class II DePuy Orthopaedics, Inc.
Nov 7, 2014 Ceramic Femoral Head. Intended for use in total hip arthroplasty applica... Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (... Class II DePuy Orthopaedics, Inc.
Oct 15, 2014 ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in ... Issuing a device correction because if the pin bushing is over loaded or inverted, there is the p... Class II DePuy Orthopaedics, Inc.
Sep 3, 2014 RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as... Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in... Class II DePuy Orthopaedics, Inc.
Aug 27, 2014 Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International ... The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin. Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. R... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manua... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sl... The product can be difficult to remove from the Distal Stem both out of the package and after pro... Class II DePuy Orthopaedics, Inc.
Mar 28, 2014 GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 223... Urgent Device Correction notifications are being sent to USA distributors with follow-up to surge... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wit... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (w... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Feb 24, 2014 REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (wi... DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexi... Class II DePuy Orthopaedics, Inc.
Dec 9, 2013 PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) U... Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presen... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel P... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. K... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. K... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel P... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Kee... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, 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.