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Browse Device Recalls

36 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 36 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 36 FDA device recalls.

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DateProductReasonClassFirm
Jan 9, 2017 STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following ... Class II Advanced Sterilization Products
Sep 27, 2016 EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 ... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
Aug 10, 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reproc... Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the... Class II Advanced Sterilization Products
Jul 27, 2015 CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution becaus... Class II Advanced Sterilization Products
Jul 17, 2015 Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Steriliz... Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System becaus... Class II Advanced Sterilization Products
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. ... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
Dec 24, 2014 Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicato... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Dec 16, 2013 STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Steriliz... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Dec 16, 2013 STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Steril... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Dec 16, 2013 STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Ster... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Nov 26, 2013 STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be... Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI... Class II Advanced Sterilization Products
Nov 11, 2013 STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low... Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization... Class II Advanced Sterilization Products
Nov 11, 2013 STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a ... Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization... Class II Advanced Sterilization Products
Oct 18, 2013 Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture se... Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare w... Class II Advanced Sterilization Products
Oct 3, 2013 STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod... Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ... Class III Advanced Sterilization Products
Sep 18, 2013 STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Steril... Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because i... Class II Advanced Sterilization Products
Sep 18, 2013 STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperat... Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRA... Class II Advanced Sterilization Products
Jul 25, 2013 STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization Sys... The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (... Class II Advanced Sterilization Products
Apr 22, 2013 STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Bi... Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indi... Class II Advanced Sterilization Products
Mar 28, 2013 EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to a... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
Mar 22, 2013 STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD ... The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... Class II Advanced Sterilization Products
Mar 22, 2013 EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to auto... Advanced Sterilization Products (ASP) has determined that a limited number of EVOTECH ECRs manufa... Class II Advanced Sterilization Products
Mar 22, 2013 STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 20... The recall was initiated because Advanced Sterilization Products (ASP) has determined that the ST... Class II Advanced Sterilization Products
Oct 3, 2012 STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validat... Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological In... Class II Advanced Sterilization Products
Sep 20, 2012 STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are... Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it... Class II Advanced Sterilization Products
Jun 28, 2012 STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, pac... Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biolo... Class II Advanced Sterilization Products
Jun 19, 2012 STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX ste... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 19, 2012 STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX steri... Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX Sys... Class III Advanced Sterilization Products
Jun 1, 2012 CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho... The recall was initiated because Advanced Sterilization Products has discovered instances of miss... Class II Advanced Sterilization Products
Mar 13, 2012 STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading... Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can... Class II Advanced Sterilization Products

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.