Browse Device Recalls
916 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 916 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 916 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 5, 2026 | VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) ... | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing... | Class II | Biomerieux Inc |
| Dec 16, 2025 | Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Rumex Disposable Diamond Dusted ILM Elevator, 12-7523 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2.... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS07... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | 25GA Subretinal Injection Cannula VS0220.25 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Tecfen Retractable Membrane Polisher, QTPR1267-23 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 I... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS02... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical I2 Injection Kit, VS0500 | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical TID Pharos Illuminated Depressor, VS0801B | XXX | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA L... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Dec 16, 2025 | Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA C... | There may be voids located in the seal of Tyvek pouches associated with identified catalog number... | Class II | Vortex Surgical Inc. |
| Nov 19, 2025 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannu... | Class II | Vortex Surgical Inc. |
| May 20, 2025 | ColoSense Test Kit, Part No. 80-001, component of ColoSense test | Multiple plate failures documented as a result of the Low Positive Template Control being too hig... | Class II | Geneoscopy, Inc. |
| Dec 26, 2024 | regard Item Number: 830106006, LD01114F - Newborn Kit containing the componen... | There is a potential for the Inline Controller to be using the spring out of specification causin... | Class I | ROi CPS LLC |
| Nov 5, 2024 | NOA Medical Industries Behavioral Health Hospital bed side rails, Product num... | Red button used to engage side rails can break or become stuck making it difficult to engage the ... | Class II | NOA Medical Industries Inc |
| Aug 23, 2024 | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net con... | The bulk product used in the recalling firm's repackaged finished product was recalled due to bac... | Class II | Young Dental Manufacturing I, LLC |
| Aug 7, 2024 | Open Shoulder, LWOS39L; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Arthroscopy Pack, MSKA45A; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | ENT, COEN27N; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Endovascular AAA Pack, ESED52B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Day Surgery General Pack, FHGE18T; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Cysto, FTCY03L; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Shoulder, SESH18I; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Endovascular AAA Pack, ESED52B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Cath Lab Pack, CECL02P; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Paracentesis Thoracente, SLPT76H; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Neuro Vascular, ANKV91A; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | PACEMAKER PACK, SLCV01J; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Nasal Sinus Pack, MTSN26B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | IR Procedure Pack, CEAT19W; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Vaginal Delivery, ASDV25B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Hand Pack, AKHD97C; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Aug 7, 2024 | Pacemaker, COPM11B; Medical convenience kit | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... | Class II | American Contract Systems, Inc. |
| Jul 24, 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med... | Class II | ROi CPS LLC |
| Jun 17, 2024 | Regard Kit containing the Microtek decanter | Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. | Class II | ROi CPS LLC |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| May 13, 2024 | Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse | Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 | Class II | Young Dental Manufacturing I, LLC |
| May 6, 2024 | American Contract Systems Gyn Laparoscopy convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Extremity convenience kit, American Contract System... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Cataract Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Special Procedure Pack convenience kit | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, Inc. |
| May 6, 2024 | American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... | Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... | Class II | American Contract Systems, 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.