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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 9, 2021 | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in... | There is an error in the new version of the package insert. The Reading Table lists the incorrec... | Class II | Biomerieux Inc |
| Nov 4, 2021 | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn... | The kit contains a non-sterile needle. | Class II | ROi CPS LLC |
| Oct 5, 2021 | Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... | The Control Level I material value was showing results exceeding the upper limit of the acceptabl... | Class III | Primus Corporation dba Trinity Biotech |
| Oct 5, 2021 | A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Con... | The Control Level I material value was showing results exceeding the upper limit of the acceptabl... | Class III | Primus Corporation dba Trinity Biotech |
| Sep 14, 2021 | Elekta Monaco - Product Usage: used to make treatment plans for patients with... | Contour changes can be saved on an unintended image set. In addition, these contour edits do not ... | Class II | Elekta Inc |
| Aug 10, 2021 | REGARD Stereotactic Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Ultrasound Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Core Biopsy Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Newborn Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Basic Cataract tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Ear Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Aug 10, 2021 | REGARD Vitrectomy Tray | Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was use... | Class II | ROi CPS LLC |
| Jul 26, 2021 | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan i... | Class II | Elekta Inc |
| Jun 24, 2021 | ETEST IMIPENEM RELEBACTAM. in vitro diagnostic | Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeru... | Class II | Biomerieux Inc |
| Jun 14, 2021 | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience k... | Instructions for use updated to include the following cautionary statement for the heel warmer, "... | Class II | ROi CPS LLC |
| Jun 14, 2021 | Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience k... | Instructions for use updated to include the following cautionary statement for the heel warmer, "... | Class II | ROi CPS LLC |
| Jun 14, 2021 | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience k... | Instructions for use updated to include the following cautionary statement for the heel warmer, "... | Class II | ROi CPS LLC |
| May 28, 2021 | Stimulen Collagen Moisturizing Lotion, ST9555B | Dose audit failure after sterilization process | Class II | Southwest Technologies Inc |
| Apr 21, 2021 | Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ... | The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula. | Class II | Anodyne Surgical |
| Mar 26, 2021 | Regard Dressing Change Tray | ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicato... | Class II | ROi CPS LLC |
| Mar 16, 2021 | VIDAS¿ CMV IgM 30 Tests | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM... | Class II | Biomerieux Inc |
| Mar 11, 2021 | HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW) | Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6)... | Class II | LIEBEL-FLARSHEIM COMPANY LLC |
| Mar 4, 2021 | Regard, Item Number 830067009, custom cardiovascular procedure kit | ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that ... | Class II | ROi CPS LLC |
| Jan 28, 2021 | VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the ext... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Jan 28, 2021 | VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with... | bioM¿rieux has identified a potential safety risk worst case of a false susceptible erroneous tes... | Class II | Biomerieux Inc |
| Nov 9, 2020 | Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. ... | Gauze sponges contained in custom kits may be flaking or fraying. | Class II | ROi CPS LLC |
| Oct 12, 2020 | Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. ... | Labeling error, incorrect expiration date. | Class II | ROi CPS LLC |
| Oct 9, 2020 | Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation | The product did not receive pre-market approval or clearance. | Class II | Primus Corporation |
| Sep 21, 2020 | Niobe ES System, Models 001-006000-1 and 001-006100-1 | There is a potential for fire in the inside computer cabinet. | Class II | Stereotaxis Inc |
| Jun 17, 2020 | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 33557... | The firm received reports from customer that the Regard Migrating Indicator shown malfunctions an... | Class II | Resource Optimization & Innovation LLC |
| May 19, 2020 | Isolation Droplet Bundle Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 19, 2020 | Respirator Crash Cart Kit | Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The ... | Class II | ROi CPS LLC |
| May 4, 2020 | Regard SRHS GIC Port A Cath, Sterile, Qty 20/case - Product Usage: The Saline... | There is a potential for the product to exhibit holes in the packaging, which impacts package int... | Class II | Resource Optimization & Innovation LLC |
| May 4, 2020 | Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Fl... | There is a potential for the product to exhibit holes in the packaging, which impacts package int... | Class II | Resource Optimization & Innovation LLC |
| Apr 20, 2020 | Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. | Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. | Class II | ROi CPS LLC |
| Apr 16, 2020 | Elekta MONACO RTP Sytem, radiation treatment planning software system - Produ... | The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour... | Class II | Elekta Inc |
| Mar 30, 2020 | Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vant... | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking ... | Class II | Elekta Inc |
| Mar 11, 2020 | The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VI... | There is a potential for the occurrence of false positive OXSF results for some Staphylococcus au... | Class II | Biomerieux Inc |
| Jan 3, 2020 | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... | ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... | Class II | ROi CPS LLC |
| Dec 31, 2019 | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw ... | Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" can... | Class II | ulrich medical USA Inc |
| Nov 22, 2019 | Monaco Radiation Treatment Planning System (RTP) System | Monaco is using the incorrect energy when optimizing and calculating dose. | Class II | Elekta Inc |
| Nov 18, 2019 | Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Ster... | Elasto-Gel Wound Dressing may be contaminated with mold. | Class II | Southwest Technologies Inc |
| Oct 30, 2019 | Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each... | Product shelf life may be shorter than that indicated on the label. | Class II | Young Dental Manufacturing Co, LLC |
| Oct 22, 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Following Customers complaints, investigations have been initiated on potentially false results o... | Class II | Biomerieux Inc |
| Sep 4, 2019 | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Sep 4, 2019 | Monaco RTP System, 5.50/5.51, radiation treatment planning system Product ... | It is possible that the forced electron density settings will be changed for some structures unin... | Class II | Elekta Inc |
| Jul 3, 2019 | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Plann... | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of... | Class II | Elekta Inc |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" includin... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 21, 2019 | Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recal... | Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube... | Class II | ROi Consolidated Service Center (CSC) |
| Mar 8, 2019 | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the ... | Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. | Class II | ulrich medical USA 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.