Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 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 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 22, 2022 | ACS Lap Chole Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 22, 2022 | ACS Cath Lab Pack | Product was sterilized with a higher than specification EO concentration. | Class II | American Contract Systems, Inc. |
| Mar 21, 2022 | Regard brand CABG Pack A and B - Spartanburg | Kits were packed into shipping boxes incorrectly. | Class II | ROi CPS LLC |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: regard Clinical Packaging ... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Mar 18, 2022 | Convenience kits containing regard IV Start Kits: (1) regard Clinical Pack... | A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the ... | Class II | ROi CPS LLC |
| Feb 28, 2022 | Regard IV Start Kit for preparing and/or dressing a peripheral vein intraveno... | A kit component, the PDI Prevantics Swab, was recalled. | Class II | Resource Optimization & Innovation LLC |
| Feb 24, 2022 | Regard Custom Procedure Kits containing BD Luer Lok Access Devices | Recalled devices were packaged in convenience kits. | Class III | ROi CPS LLC |
| Jan 13, 2022 | Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile | Products are mislabeled with the incorrect product identification on individual kit labeling. | Class II | ROi CPS LLC |
| Dec 29, 2021 | YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR ... | The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Ind... | Class II | Young Dental Mfg Co I LLC |
| Dec 20, 2021 | API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... | Risk of misidentification or delayed results with the absence of identification due to thermoform... | Class II | Biomerieux Inc |
| Nov 30, 2021 | Regard, T AND A - Rogers, sterilized convenience kits | Kits lacks rubber latex warning label. | Class II | ROi CPS LLC |
| 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 |
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.