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
Dec 22, 2017 Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Numbe... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arteria... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheter... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-2430... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part ... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use wi... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume I... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-428... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 22, 2017 (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) ... Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the pro... Class II Arrow International Inc
Dec 21, 2017 ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage:... Certain lots may be missing information at the bottom of the lid including the lot number, expira... Class II Arrow International Inc
Dec 20, 2017 Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370... The controls and calibrators contained within the cocaine test kit may cause false positive resul... Class III OraSure Technologies, Inc.
Dec 15, 2017 ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: ... Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize... Class II Arrow International Inc
Dec 14, 2017 Dynavox T15 Speech Generating Device ( including Batteries) The battery is integral to the device. If the device sits unused and is not charged for a length... Class II Dynavox Systems Llc
Dec 14, 2017 Dynavox T10 Speech Generating Device ( including Batteries) The battery is integral to the device. If the device sits unused and is not charged for a length... Class II Dynavox Systems Llc
Dec 13, 2017 11-VI Incorporated Laser diode component Non-certified laser diode compone... Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit. Class II Ii - Vi Incorporated
Nov 28, 2017 Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular inf... Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut ... Class II Cook Vascular Inc.
Nov 27, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ C... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CV... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide sho... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ C... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usag... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter ... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) ... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: ... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 27, 2017 ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usa... Some of the products listed in the recall may be missing a sticker that contains the lot number, ... Class II Arrow International Inc
Nov 22, 2017 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyuretha... The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked ... Class II Medical Components, Inc dba MedComp
Nov 14, 2017 Pressure Injectable Multi- Lumen CVC Kit Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue F... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemo... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, ... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 14, 2017 ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to ... Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line... Class II Arrow International Inc
Nov 8, 2017 SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... Class II Siemens Medical Solutions USA, Inc
Nov 8, 2017 SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnosti... There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... Class II Siemens Medical Solutions USA, Inc
Nov 8, 2017 SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnosti... There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... Class II Siemens Medical Solutions USA, Inc
Nov 8, 2017 SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic sy... There is a potential risk of unnecessary radiation exposure due to a software issue found in the ... Class II Siemens Medical Solutions USA, Inc
Oct 26, 2017 Arterial Access Tray, introducer catheter; Model: GU-04020 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04020-C The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04120 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International Inc
Oct 26, 2017 Radial Artery Catheterization Kit; Model: AK-04018 The povidone iodine prep pads included in certain kits and trays do not meet the requirements for... Class II Arrow International 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.