Browse Device Recalls

3,192 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,192 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 3,192 FDA device recalls.

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DateProductReasonClassFirm
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly prot... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly pr... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Dec 3, 2012 SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly prote... An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in im... Class II DePuy Orthopaedics, Inc.
Nov 30, 2012 Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy... Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specific... Class II Biomet Spine, LLC
Nov 28, 2012 Pinnacle Cancellous Screw Packaging: Product is housed within a polyuretha... DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Sc... Class II DePuy Orthopaedics, Inc.
Nov 19, 2012 Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioA... Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that c... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Nov 8, 2012 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescr... The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in... Class II Medline Industries Inc
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 device... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/c... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Nov 2, 2012 KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... Class II King Systems Corp.
Oct 25, 2012 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... Class III Volk Optical Inc
Oct 4, 2012 BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gaug... A report of an event was received indicating that upon opening a box containing 10 sterile cannul... Class II Baylis Medical Company Inc.
Oct 4, 2012 PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... Damage to the packaging may have compromised the sterility of the device. Class II Ethicon Endo-Surgery Inc
Sep 13, 2012 CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Sep 13, 2012 CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are pri... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Sep 13, 2012 CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CP... Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petit... Class II Zimmer, Inc.
Aug 22, 2012 S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into ... Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner becaus... Class II DePuy Orthopaedics, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somer... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 21, 2012 ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed... SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue withi... Class I Ethicon, Inc.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 17, 2012 Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 ... Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone... Class II Stryker Howmedica Osteonics Corp.
Aug 10, 2012 IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Ca... It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are l... Class II Immunodiagnostics Systems Ltd
Aug 9, 2012 Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Num... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IR... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Aug 9, 2012 Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: ... Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have... Class II Applied Medical Resources Corp
Jul 31, 2012 DePuy Custom Implant Devices Packaging: Packaging was not standardized o... In connection with a Warning Letter received from the U.S. Food & Drug Administration on December... Class II DePuy Orthopaedics, Inc.
Jul 24, 2012 Altrx" Altralinked" Polyethylene liners Description: An acetabular liner i... In the recalled lot, the products were not machined according to the production router, a size 52... Class II DePuy Orthopaedics, Inc.
Jul 20, 2012 TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... Product is missing the label on the internal packaging. Class III Teleflex Medical
Jul 18, 2012 Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers... Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 13, 2012 Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ... Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ... Class II Westone Laboratories, Inc.
Jun 15, 2012 Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, 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.