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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 15, 2017 | Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... | The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... | Class II | Custom Assemblies Inc |
| Jun 15, 2017 | Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine der... | During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (... | Class II | TEI Biosciences |
| Jun 15, 2017 | Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 15, 2017 | Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... | Class II | Steris Corporation |
| Jun 14, 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used ... | Reports of the device failure involving delivering continuous pressure to the calf garment and no... | Class II | Arjo, Inc. dba ArjoHuntleigh |
| Jun 14, 2017 | mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Ma... | Potential failure in the balloon bond in the inner catheter stem, leading to the separation of th... | Class II | Medspira, Llc |
| Jun 14, 2017 | SMARTABLATE RF System Generator | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and ... | Class II | Biosense Webster, Inc. |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... | Manufacturing process used to assemble the circuit board may result in some devices experiencing ... | Class II | Cyberonics, Inc |
| Jun 13, 2017 | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No... | Manufacturing process used to assemble the circuit board may result in some devices experiencing ... | Class II | Cyberonics, Inc |
| Jun 13, 2017 | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... | When the user has not set up any user preference on the sorting order to render the study images ... | Class II | Merge Healthcare, Inc. |
| Jun 13, 2017 | BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The B... | Presence of loose polypropylene foreign matter above release specification. | Class II | Becton Dickinson & Company |
| Jun 12, 2017 | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Or... | The firm identified the potential for biased results to be generated when processing VITROS PHYT ... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2017 | Alaris PC Unit, Model 8015 | BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios whi... | Class II | CareFusion 303, Inc. |
| Jun 12, 2017 | INVUITY(R) PhotonBlade(TM), REF PB1 | A small number of customer observations were recently received which related to possible unintend... | Class II | Invuity, Inc. |
| Jun 12, 2017 | DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE | A raw material anomaly was discovered in four lots of raw material and has the potential to be on... | Class II | Zimmer Biomet, Inc. |
| Jun 12, 2017 | Arrow Glide Thru Peel-Away Sheath/Dilator Introducer | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 12, 2017 | Alaris Pump Module model 8100 | There is a potential risk that could cause unintended flow in the older, centered sear door latch... | Class II | CareFusion 303, Inc. |
| Jun 12, 2017 | Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Bloo... | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... | Class II | Roche Diabetes Care, Inc. |
| Jun 12, 2017 | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and A... | Arrow is recalling additional lots that were identified as part of an active recall. Arrow is rec... | Class II | Arrow International Inc |
| Jun 12, 2017 | Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood G... | Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short batte... | Class II | Roche Diabetes Care, Inc. |
| Jun 11, 2017 | Tosoh¿Sorter 9tray, Product Code 022931and Tosoh¿Sorter 19tray, Product Code ... | This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... | Class II | Tosoh Bioscience Inc |
| Jun 11, 2017 | Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 0229... | This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The ... | Class II | Tosoh Bioscience Inc |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press... | Class II | Kelyniam Global, Inc. |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press... | Class II | Kelyniam Global, Inc. |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press... | Class II | Kelyniam Global, Inc. |
| Jun 10, 2017 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing press... | Class II | Kelyniam Global, Inc. |
| Jun 9, 2017 | Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW... | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... | Class II | Natus Neurology Inc |
| Jun 9, 2017 | Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. ... | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... | Class II | Natus Neurology Inc |
| Jun 9, 2017 | Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog C... | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... | Class II | Natus Neurology Inc |
| Jun 9, 2017 | Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Inten... | Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... | Class II | Natus Neurology Inc |
| Jun 9, 2017 | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile P... | Identification of excess plastic on the tip of the cannula. | Class II | Sorin Group USA, Inc. |
| Jun 9, 2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascu... | Penumbra has identified an issue in these four lots involving a raw material component of the del... | Class I | Penumbra Inc. |
| Jun 8, 2017 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN ... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 8, 2017 | Accu-Chek Connect diabetes management software app, Catalog number 0756246200... | Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. ... | Class II | Roche Diabetes Care, Inc. |
| Jun 7, 2017 | Brilliance iCT (Model No. 728306), 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 | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDO... | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. Th... | Class II | Randox Laboratories Ltd. |
| Jun 7, 2017 | Brilliance Big Bore Oncology CT (Model No. 728243) 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 | Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product... | 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 130 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, 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 | 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 | 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 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021),... | An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introdu... | Class II | Terumo Medical 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.