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Browse Device Recalls

317 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 317 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 317 FDA device recalls.

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DateProductReasonClassFirm
Jan 21, 2016 Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity of the pouch may be d... Class II Stryker Howmedica Osteonics Corp.
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instruct... Class II Stryker Howmedica Osteonics Corp.
Oct 15, 2015 Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmed... Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the U... Class II Stryker Howmedica Osteonics Corp.
Sep 29, 2015 Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, R... Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints w... Class II Stryker Howmedica Osteonics Corp.
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants... Class II Stryker Howmedica Osteonics Corp.
Sep 8, 2015 Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis... Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion ... Class II Stryker Howmedica Osteonics Corp.
Jun 25, 2015 Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant compo... it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, wa... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size ... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... Class II Stryker Howmedica Osteonics Corp.
May 12, 2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part... Class II Stryker Howmedica Osteonics Corp.
Feb 27, 2015 Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 ... Class II Stryker Howmedica Osteonics Corp.
Feb 12, 2015 Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Dist... Potential for weld disassociation of the cross pin, which could lead to loose or disassociated tr... Class II Stryker Howmedica Osteonics Corp.
Feb 3, 2015 LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4... Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (p... Class II Stryker Howmedica Osteonics Corp.
Dec 15, 2014 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E ... Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.,... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Aug 15, 2014 Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica ... The peel strength of the inner blister may have been below internal validated requirements. The ... Class II Stryker Howmedica Osteonics Corp.
Jul 24, 2014 Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-... Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a differ... Class II Stryker Howmedica Osteonics Corp.
May 1, 2014 Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE P... Tritanium Patella Inserter Instrument fracture during implantation. . Class II Stryker Howmedica Osteonics Corp.
Feb 3, 2014 Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalo... Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angl... Class II Stryker Howmedica Osteonics Corp.
Dec 6, 2013 Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) ... Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customi... Class II Stryker Howmedica Osteonics Corp.
Nov 20, 2013 Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single u... Stryker received reports from the field of the impaction plate dissociating/fracturing from the m... Class II Stryker Howmedica Osteonics Corp.
Nov 7, 2013 Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher S... Stryker became aware during laboratory testing that there is a potential that the seal integrity ... Class II Stryker Howmedica Osteonics Corp.
Oct 25, 2013 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Ang... Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was iden... Class II Stryker Howmedica Osteonics Corp.
Oct 10, 2013 VariAx Compression Plating System Stryker received two reports indicating that during screw insertion under a high lateral angle a ... Class II Stryker Howmedica Osteonics Corp.
Oct 1, 2013 Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stry... Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM sur... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Sep 30, 2013 Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surg... Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip a... Class II Stryker Howmedica Osteonics Corp.
Jul 8, 2013 Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) ... Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot... Class II Stryker Howmedica Osteonics Corp.
Jul 2, 2013 Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedul... Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. Class II Stryker Howmedica Osteonics Corp.
May 21, 2013 GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedic... Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. Class II Stryker Howmedica Osteonics Corp.
Mar 28, 2013 Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Loc... Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Dril... Class II Stryker Howmedica Osteonics Corp.
Mar 25, 2013 Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit pe... Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathal... Class II Stryker Howmedica Osteonics Corp.
Feb 23, 2013 Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. How... Stryker received reports from the field indicating that the handle detached from the cam of the B... Class II Stryker Howmedica Osteonics Corp.
Jan 24, 2013 Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and ... The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" ... Class II Stryker Howmedica Osteonics Corp.
Dec 20, 2012 Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog N... Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. Class II Stryker Howmedica Osteonics Corp.

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.