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.

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DateProductReasonClassFirm
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.