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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

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DateProductReasonClassFirm
Mar 5, 2018 ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthe... Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Ad... Class II Synthes, Inc.
Mar 5, 2018 ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is i... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw len... Class II Synthes (USA) Products LLC
Mar 5, 2018 ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 2, 2018 BD MAX DNA MMK Lab Use, catalog no. 442828 The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... Class III Becton Dickinson & Co.
Mar 2, 2018 Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI In... There is potential for a cart with disinfected goods to unload without the trolley being docked. ... Class II Getinge Disinfection Ab
Mar 2, 2018 BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829 The package insert incorrectly lists the volume of the primer and probe diluent to use for the re... Class III Becton Dickinson & Co.
Mar 2, 2018 Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI83... Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instrume... Class II Randox Laboratories Ltd.
Mar 2, 2018 BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 70... Beckman Coulter has determined that there is a potential for under-reporting casts. This can occu... Class II Beckman Coulter Inc.
Mar 2, 2018 Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI In... There is potential for a cart with disinfected goods to unload without the trolley being docked. ... Class II Getinge Disinfection Ab
Mar 2, 2018 BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... Class II Beckman Coulter Inc.
Mar 1, 2018 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotatin... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Cl... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The p... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is... Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS... Class II bioMerieux, Inc.
Mar 1, 2018 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: ... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Mar 1, 2018 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Ch... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, Inc.
Mar 1, 2018 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cle... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotati... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper P... Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually co... Class II Zimmer Biomet, 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.