Browse Device Recalls
960 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 960 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 960 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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. |
| Dec 12, 2025 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Hologic, Inc |
| Dec 11, 2025 | The product is used for the evaluation of the intrinsic coagulation pathway, ... | Potential for microbial contamination. | Class II | Instrumentation Laboratory |
| Nov 17, 2025 | Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"... | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may r... | Class II | Sheathing Technologies Inc |
| Nov 12, 2025 | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10... | Products may contain contamination, which may result in a darker or brown media color. | Class II | Remel, Inc |
| Oct 1, 2025 | Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product De... | Potential for contamination with cotton fibers. | Class II | ENDOMAGNETICS LTD |
| Oct 1, 2025 | Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product D... | Potential for contamination with cotton fibers. | Class II | ENDOMAGNETICS LTD |
| Aug 29, 2025 | DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressi... | Wound dressing may have foreign matter on the product. | Class II | ConvaTec, Inc |
| Jul 24, 2025 | MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan pan... | Due to the likely presence of contamination in well(s). | Class II | Beckman Coulter, Inc. |
| Jul 21, 2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA Satellite. Product Code: All references. All software versions. The ST... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 21, 2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti... | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap... | Class II | Diagnostica Stago, Inc. |
| Jul 11, 2025 | Blood/EMB, Levine 100/PK, Product Number R02041 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Strep Selective II Agar, Product Number R01859 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood/MacConkey Biplate 100/PK, Product Number R02049 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 11, 2025 | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Remel, Inc |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jul 1, 2025 | Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy ... | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise st... | Class II | Carefree Surgical Specialties |
| Jun 20, 2025 | One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. | Potential contamination with small burrs, which if detach could be inhaled and result in potentia... | Class II | Intersurgical Inc |
| Jun 20, 2025 | One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. | Potential contamination with small burrs, which if detach could be inhaled and result in potentia... | Class II | Intersurgical Inc |
| May 22, 2025 | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 5, 2025 | Access Testosterone assay, Catalog Number 33560 | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to s... | Class II | Beckman Coulter, Inc. |
| May 5, 2025 | Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V | Recent post-market surveillance data suggests a possible association of higher microbial contamin... | Class II | Olympus Corporation of the Americas |
| May 2, 2025 | Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 | During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... | Class II | Healthmark Industries Co., Inc. |
| May 2, 2025 | ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) | During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... | Class II | Healthmark Industries Co., Inc. |
| Apr 4, 2025 | KliniTray. KlinioTray. Tissue resection margin examination board/small. Model... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Apr 4, 2025 | KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examinat... | Potential for microbial contamination. | Class II | Klinika Mdical Gmb |
| Mar 13, 2025 | Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage... | The potential for risk of microbiological contamination of products due to inability to ensure st... | Class II | INSTITUT GEORGES LOPEZ |
| Feb 13, 2025 | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro dia... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Feb 13, 2025 | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnosti... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Nov 26, 2024 | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassa... | Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or... | Class II | Beckman Coulter, Inc. |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF ... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEM... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | See DocMan | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 21, 2024 | Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V;... | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.