Oct 21, 2026
Z-0167-2027
TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
Howmedica Osteonics Corp.
- FSM
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Oct 21, 2026
Z-0166-2027
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics Corp.
- FSM
- Class II
- Ongoing
Oct 21, 2026
Z-0165-2027
TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
Howmedica Osteonics Corp.
- FSM
- Class II
- Ongoing
Oct 21, 2026
Z-0164-2027
TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
Howmedica Osteonics Corp.
- FSM
- Class II
- Ongoing
Oct 21, 2026
Z-0163-2027
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Orde…
Cook Incorporated
- FBK
- Class II
- Ongoing
Oct 21, 2026
Z-0162-2027
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics, Inc.
- DOF
- Class III
- Ongoing
Oct 21, 2026
Z-0161-2027
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 ELITE, REF: 700-337…
Beckman Coulter, Inc.
- KQO
- Class II
- Ongoing
Oct 21, 2026
Z-0160-2027
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Beckman Coulter, Inc.
- KQO
- Class II
- Ongoing
Oct 21, 2026
Z-0159-2027
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control,…
Microgenics Corporation
- JJY
- Class II
- Ongoing
Oct 21, 2026
Z-0158-2027
Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Bili…
W L Gore & Associates, Inc.
- FGE
- Class II
- Ongoing
Oct 21, 2026
Z-0157-2027
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
In2bones USA, LLC
- HWC
- Class II
- Ongoing
Oct 21, 2026
Z-0156-2027
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Steris Corporation
- FEB
- Class II
- Ongoing
Oct 21, 2026
Z-0155-2027
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Steris Corporation
- FEB
- Class II
- Ongoing
Oct 21, 2026
Z-0154-2027
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris Corporation
- FEB
- Class II
- Ongoing
Oct 21, 2026
Z-0153-2027
PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
Ethicon, LLC
- GAQ
- Class II
- Ongoing
Oct 21, 2026
Z-0151-2027
Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Cod…
Baxter Healthcare Corporation
- FSA
- Class II
- Ongoing
Oct 21, 2026
Z-0150-2027
Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 Kit), RFIT-ASY-0135…
BioFire Diagnostics, LLC
- QSN
- Class II
- Ongoing
Oct 21, 2026
Z-0149-2027
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)…
BioFire Diagnostics, LLC
- QDS
- Class II
- Ongoing
Oct 21, 2026
Z-0148-2027
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-A…
BioFire Diagnostics, LLC
- QDP
- Class II
- Ongoing
Oct 21, 2026
Z-0147-2027
FORWARD Gunshot Wound Kit; Model: AFT-GSW;
INTEGRATED MEDCRAFT LLC
- OHO
- Class II
- Ongoing
Oct 21, 2026
Z-0146-2027
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)
SI-BONE, Inc.
- OUR
- Class II
- Ongoing
Oct 21, 2026
Z-0145-2027
Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Ferno-Washington Inc
- FPO
- Class II
- Ongoing
Oct 21, 2026
Z-0144-2027
Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
Sarnova HC, Llc
- CCX
- Class II
- Ongoing
Oct 21, 2026
Z-0143-2027
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific Corporation
- FGE
- Class II
- Ongoing
Oct 21, 2026
Z-0142-2027
NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. N…
Neuronetics, Inc.
- OBP
- Class II
- Ongoing