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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

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

2,939 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,939 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 2,939 FDA device recalls in PA.

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DateProductReasonClassFirm
Apr 11, 2018 PICC Catheter Trimmer ; Product Code:PC-00001-T Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port f... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIH... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes:... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Extension Line Slide Clamps; Product codes: SA-09847 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Arterial Catheterization Kit; Product Code:NA-04550-1A Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheter... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Radial Arterial Access Kit; Product Code: ASK-04001-BID2 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Epidural Needle; Product Codes: AN-05501 and AN-05505 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes:... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Codes: ASK-00001-1A Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port a... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: ... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Shea... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Cathet... Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 Maximal Barrier Drape; Product Code: ASK-04000-HMC Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 11, 2018 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 Product sterility may be compromised due to unsealed packaging. Class II Arrow International Inc
Apr 4, 2018 CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLS... Unusually high number of total images/unassigned events may require additional time and effort fo... Class II Menarini Silicon Biosystems
Apr 2, 2018 Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... Class II Synthes (USA) Products LLC
Apr 2, 2018 Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... Class II Synthes (USA) Products LLC
Mar 27, 2018 Syngo.Via VB20A model 1049610 Functionality in the report sections "Findings Information" and "Summary of Measured Findings" no... Class II Siemens Medical Solutions USA, Inc
Mar 20, 2018 Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Ext... There is an error in the caddy artwork that misidentifies a specific plate and screw. Class II Epic Extremity, LLC
Mar 20, 2018 Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.... There is an error in the caddy artwork that misidentifies a specific plate and screw. Class II Epic Extremity, LLC
Mar 19, 2018 Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extr... There is a potential for the connection screw of the stem extractor to break. Class II Synthes, Inc.
Mar 5, 2018 Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined 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 Part no. 690.380, Graphic Case F/7.3mm 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 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 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 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 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 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 Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The pr... The automatic ventilation may fail if the position detection of the motor is disturbed. If the ve... Class I Draeger Medical, Inc.
Feb 28, 2018 PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 28, 2018 PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... Potential friction holes may affect the sterility of the product. Class II Vygon U.S.A.
Feb 23, 2018 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product ... There is the potential for connection failures related to the female two-part luer to hemodialysi... Class II Medical Components, Inc dba MedComp
Feb 23, 2018 REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair ... There is the potential for connection failures related to the female two-part luer to hemodialysi... Class II Medical Components, Inc dba MedComp

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.