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Browse Device Recalls

87 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 87 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 87 FDA device recalls.

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DateProductReasonClassFirm
Apr 26, 2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-4... Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport... Class II Stryker Howmedica Osteonics Corp.
Dec 2, 2016 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound... Reunion TSA Peg Alignment Sound broke during surgery. Class II Stryker Howmedica Osteonics Corp.
Nov 9, 2016 GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... A review of packaging revealed the seal integrity of the pouch may be compromised. More specifica... Class II Stryker Howmedica Osteonics Corp.
Aug 29, 2016 LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, R... Stryker received several complaints describing incidence of harm secondary to taper lock failure ... Class II Stryker Howmedica Osteonics Corp.
Aug 18, 2016 Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... Stryker Orthopaedics has received reports of the thread length protruding past the dome of the ac... Class II Stryker Howmedica Osteonics Corp.
Aug 1, 2016 Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... Upon failure of the press-fit, the clamping sub components and pins could disassociate from the S... Class II Stryker Howmedica Osteonics Corp.
Jul 1, 2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed t... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis reveal... Class II Stryker Howmedica Osteonics Corp.
Jun 23, 2016 Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... It was reported that the secondary locking mechanism, and its corresponding components, disassoci... Class II Stryker Howmedica Osteonics Corp.
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recomme... Class II Stryker Howmedica Osteonics Corp.
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm 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.
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... 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, Gamma K-Wire 3.2x450 mm, UNS-Thread 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, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... 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, Recon Product Usage: Intended for the temp... 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, 2.5x800 mm 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, Smooth-Tipped, 2.2 x 800mm 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 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... 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, 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.

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.