Browse Device Recalls

917 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 917 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 917 FDA device recalls in MO.

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DateProductReasonClassFirm
May 23, 2013 BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: Th... The product does not meet the firm's size standards, the product was produced in the incorrect size. Class II Prism Medical Services USA
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-ST... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapar... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push ... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Lapa... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-S... Product coatings require 510K approval. Class II Progressive Medical Inc
Apr 12, 2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparo... Product coatings require 510K approval. Class II Progressive Medical Inc
Mar 22, 2013 LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit. The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid ... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Numb... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Mar 22, 2013 LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. Fi... The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by t... Class III Lighthouse For The Blind
Feb 18, 2013 VITEK 2 Compact computer system when equipped with the following Hewlett-Pack... There is a potential to link an isolate result to the wrong patient and then upload the results t... Class II Biomerieux Inc
Feb 18, 2013 VITEK 2 XL computer system when equipped with the following Hewlett-Packard P... There is a potential to link an isolate result to the wrong patient and then upload the results t... Class II Biomerieux Inc
Feb 18, 2013 VITEK 2 60 computer system when equipped with the following Hewlett-Packard P... There is a potential to link an isolate result to the wrong patient and then upload the results t... Class II Biomerieux Inc
Feb 6, 2013 bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. ... The product package did not contain the correct version of the package insert listing the limitat... Class II Biomerieux Inc
Jan 27, 2013 Prism Medical C-Series Carry Bar, Class I, model number 360755. The inten... The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal inse... Class II Prism Medical Services USA
Oct 17, 2012 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: T... The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Sa... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument T... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument so... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, ... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument s... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrumen... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrume... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrum... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux Inc
Oct 16, 2012 bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instr... The product may mislabel patient information on culture specimen bottles due to a software miscom... Class II Biomerieux 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.