Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: C... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) ... Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or b... Class II Cenorin, LLC
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolp... Lack of sterility assurance. There is a defect in the primary packaging of the device, which may... Class II DeRoyal Industries Inc
Jun 7, 2017 Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usag... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Materia... Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol... Class II Siemens Healthcare Diagnostics, Inc
Jun 7, 2017 Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9... Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (... Class II Medtronic Navigation, Inc.
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Co... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... An intermittent electrical problem that could lead to a loss of system power due to a loose screw... Class II Mako Surgical Corporation
Jun 7, 2017 ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) M... Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or b... Class II Cenorin, LLC
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 7, 2017 Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021),... An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... Class II Terumo Medical Corp
Jun 7, 2017 IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Produ... It was reported that scanners running certain software versions provide confusing information in ... Class II Philips Medical Systems (Cleveland) Inc
Jun 6, 2017 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenz... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Jun 6, 2017 Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Jun 6, 2017 Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 1... Potential for liquid entry Class II Siemens Medical Solutions USA, Inc
Jun 6, 2017 Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10... Potential for liquid entry Class II Siemens Medical Solutions USA, Inc
Jun 6, 2017 Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchang... Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite At... Class II Spectranetics Corporation
Jun 6, 2017 Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: ... Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio o... Class II Draegar Medical Systems, Inc.
Jun 6, 2017 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respirat... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Jun 6, 2017 Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseri... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Jun 6, 2017 Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Ve... Real-time shelf life testing failed at 24 months Class II Microbiologics Inc
Jun 6, 2017 Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007... Potential for liquid entry Class II Siemens Medical Solutions USA, Inc
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 ECHO POR FMRL NC 9X125, model # 192009 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Lateral Troch Plate Full Crimp - 254mm, model # 350837 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CER BIOLOXD OPTION HD 32MM, model # 650-1056 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 COMP PRIMARY STEM 8MM MINI, model # 113628 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H78... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) ... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T ... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
Jun 5, 2017 RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 OSS CEMENTED IM STEM 12X150, model # 150366 Possibility that the patient label inside the product box was incorrectly labeled. The outer box... Class II Zimmer Biomet, Inc.
Jun 5, 2017 Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (U... The firm is recalling product that has the potential to not function during use. The product af... Class II Angiodynamics, Inc.
Jun 5, 2017 Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... The design verification for the previous packaging configuration G928 does not cover the 70cm wir... Class II Zimmer Biomet, Inc.
Jun 5, 2017 CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented... The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been... Class II Smiths Medical ASD 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.