Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 126 - 150 of 2,579 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706; 6) CAROTID CDS-LF, Medline product number/SKU CDS983139B. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.	FDA Z-0173-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 2, 2026	Details
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.	FDA Z-0143-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 10, 2026	Details
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results	FDA Z-0148-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 12, 2026	Details
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.	FDA Z-0167-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 16, 2026	Details
BD Phoenix Panel NMIC-306. Catalog Number: 449292. Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.	FDA Z-0140-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 13, 2026	Details
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.	FDA Z-0134-2027	Medical Device	High	Oct 21, 2026 Recall: Jul 31, 2026	Details
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.	FDA Z-0180-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 31, 2026	Details
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.	FDA Z-0168-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 2, 2026	Details
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.	FDA Z-0187-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 27, 2026	Details
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model Number 09-1-011; 3) VENTED INSTRUMENT GUARD 5/64 X 3/4 - BLUE, Model Number 09-1-012; 4) BLUE VENTED INSTRUMENT GUARD 5/64 X 3/4, Model Number 09-1-012; 5) VENTED INSTRUMENT GUARD 7/64 X 3/4 - GREEN, Model Number 09-1-013; 6) GREEN VENTED INSTRUMENT GUARD 7/64 X 3/4, Model Number 09-1-013; 7) VENTED INSTRUMENT GUARD 1/8 X 1 - RED, Model Number 09-1-014; 8) RED VENTED INSTRUMENT GUARD 1/8 X 1, Model Number 09-1-014; 9) VENTED INSTRUMENT G Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated.	FDA Z-0188-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 7, 2026	Details
BD Phoenix Panel NMIC-312. Catalog Number: 449082. Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.	FDA Z-0139-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 13, 2026	Details
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638 DYNJ908720B UROLOGY ROBOT ADD ON PACK DYNJ85189 Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.	FDA Z-0181-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 31, 2026	Details
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.	FDA Z-0144-2027	Medical Device	High	Oct 21, 2026 Recall: Jun 12, 2026	Details
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.	FDA Z-0182-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 31, 2026	Details
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528P; 5) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312J; 6) Product Name CATH LAB ENDO AAA, Medline Kit Number/SKU DYNJ35312K; 7) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ43937; 8) Product Name OPEN HEART PACK, Medline Kit Number/SKU DYNJ80549D; 9) Product Name CV PART 1 AN Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.	FDA Z-0169-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 2, 2026	Details
Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results	FDA Z-0149-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 12, 2026	Details
FORWARD Gunshot Wound Kit; Model: AFT-GSW; Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.	FDA Z-0147-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 25, 2026	Details
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.	FDA Z-0156-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 21, 2026	Details
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product number/SKU DYNJ0665837G; 3) AV FISTULA, Medline product number/SKU DYNJ900454C; 4) VEIN PACK SHD, Medline product number/SKU DYNJ68420D; 5) PACK VASCULAR BYPASS, Medline product number/SKU DYNJ905692J; 6) PRODUCT VASCULAR LAFAYETTE, Medline product number/SKU DYNJ908620D; 7) CHRISTUS SPOHN AV ACCESS PACK, Medline product number/SKU DYNJ60973A; 8) TOL VEIN PACK, Medline product number/SKU DYNJ80861F; 9) THROMBECTOMY PACK-LF, Medline product Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.	FDA Z-0171-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 2, 2026	Details
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.	FDA Z-0153-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 8, 2026	Details
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.	FDA Z-0135-2027	Medical Device	High	Oct 21, 2026 Recall: Jul 31, 2026	Details
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The potential for the devices to be mislabeled with the incorrect length.	FDA Z-0158-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 3, 2026	Details
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.	FDA Z-0159-2027	Medical Device	High	Oct 21, 2026 Recall: Aug 17, 2026	Details
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in close proximity.	FDA Z-0154-2027	Medical Device	High	Oct 21, 2026 Recall: Sep 21, 2026	Details
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device.	FDA Z-0136-2027	Medical Device	High	Oct 21, 2026 Recall: Jul 31, 2026	Details

Showing 126 - 150 of 2,579 product recalls

Prev 1 ... 4 5 6 7 8 ... 104 Next

Medical Device Recalls Today

Review FDA device recalls and early alerts for equipment, software, monitors, implants, diagnostic tools and patient-use devices.

Search The Device Label

Use the device name, company, product code, UDI, model, catalog number, serial number, lot number, software version or implant card details.

Recall Class And Risk Level

Class I recalls are generally the most serious. Read the FDA notice for patient risk, affected devices, correction/removal steps and clinical action.

What To Check On A Device Label

If the device supports or monitors health, do not stop treatment based only on a search result. Confirm with the official notice and your clinician when needed.

How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Match The Exact Medical device

Use each recall result to compare device name, company, product code, model, serial, lot number, UDI and software version. A similar name is not enough; recalls often apply only to specific versions or production ranges.

Read The Recall Hazard

Check the notice for FDA recall class, patient risk, correction, removal and clinical action. This helps you decide whether the item should be stopped immediately or handled through a normal remedy process.

Check Where It Was Sold

Review retailer, online marketplace, state, distribution and purchase-date details when they are available. Some recalls apply only to certain stores or channels.

Follow The Official Remedy

Use the linked official notice for final instructions such as repair, replacement, refund, disposal, software update, stop-use or company contact.