Browse Device Recalls

1,003 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,003 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 1,003 FDA device recalls.

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DateProductReasonClassFirm
Aug 14, 2026 Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Num... Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... Class II American Nitrile Operations Llc
Aug 14, 2026 Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog N... Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... Class II American Nitrile Operations Llc
Aug 14, 2026 Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Num... Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... Class II American Nitrile Operations Llc
Aug 11, 2026 Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DY... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) AC... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYND... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; ... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYND... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number:... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 11, 2026 Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM... The kits contain certain lots of sterile applicators which may contain fungal contamination that ... Class I Medline Industries, LP
Aug 3, 2026 Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... Contamination within the release test equipment flow path could have affected the accuracy of the... Class II Baxter Healthcare Corporation
Jul 31, 2026 Convenience kits CATARACT PACK DYNJ59881A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jun 25, 2026 Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 25, 2026 Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tra... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 25, 2026 Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray ... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 25, 2026 Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter ... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 25, 2026 Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ A... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 25, 2026 Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-... Due to complaints received indicating presence of contamination on the surface of pericare wipes ... Class II C.R. Bard Inc
Jun 24, 2026 Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM033... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 24, 2026 V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... Class II Covidien, LP
Jun 12, 2026 Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2)... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295 The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC0... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920;... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CD... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) P... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, ... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS8600... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702B The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG D... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375C The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM14... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Jun 12, 2026 Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYN... The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a poten... Class II Medline Industries, LP
Apr 22, 2026 BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. Contamination to in-vitro diagnostic test may result in false positives. Class II BioFire Diagnostics, LLC
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.

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.