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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
Mar 30, 2022 Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Tri... Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial C... Class II Howmedica Osteonics Corp.
Jan 14, 2022 Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-032 Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... Class II Howmedica Osteonics Corp.
Jan 14, 2022 Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232 Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head i... Class II Howmedica Osteonics Corp.
Dec 30, 2021 Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044 There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... Class II Howmedica Osteonics Corp.
Dec 30, 2021 Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440 There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and E... Class II Howmedica Osteonics Corp.
Dec 21, 2021 Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Dec 21, 2021 32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032 There is a potential for the outer Tyvek lid to de-bond from the sealed package. Class II Howmedica Osteonics Corp.
Nov 24, 2021 Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage... Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel ... Class II Howmedica Osteonics Corp.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028 XXX Class II Howmedica Osteonics Corp.
Oct 15, 2021 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 There is a potential for the outer white Tyvek lid to debond from the sealed package. Class II Howmedica Osteonics Corp.
Jul 1, 2021 Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a w... Class II Howmedica Osteonics Corp.
Mar 5, 2021 Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Re... The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (L... Class II Howmedica Osteonics Corp.
Feb 10, 2021 Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,... Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Bas... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 1, 2020 Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010 Shipments were transported outside of the required refrigerated temperature conditions. Potential... Class II Howmedica Osteonics Corp.
Nov 7, 2019 Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless... May have a missing locking wire causing delay in surgery while retrieving a back-up device or imp... Class II Howmedica Osteonics Corp.
Oct 3, 2019 Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to... Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wa... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - ... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - P... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal A... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Aug 19, 2019 TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - ... Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral com... Class II Howmedica Osteonics Corp.
Jun 18, 2019 Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm... Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the re... Class II Howmedica Osteonics Corp.
Nov 28, 2018 Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Int... The surgical technique is being updated to caution against misuse due to reports of cage fracture... Class II Howmedica Osteonics Corp.
Nov 26, 2018 Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blu... Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface... Class II Howmedica Osteonics Corp.
Nov 15, 2018 HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 Class II Howmedica Osteonics Corp.
Nov 15, 2018 HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19 Class II Howmedica Osteonics Corp.
Sep 12, 2018 Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Pro... The firm received complaints related to the locking mechanism on the steerable inserter not funct... Class II Howmedica Osteonics Corp.
Sep 10, 2018 Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm... Potential for outer pouch sterile barrier to be compromised Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II Howmedica Osteonics Corp.
May 22, 2018 LFIT Anatomic CoCr Femoral Heads, 6260-9-036 The recalling firm has received a higher than expected number of complaints documenting femoral h... Class II 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.