Aug 19, 2026
Z-2938-2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA Inc
- 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
Aug 19, 2026
Z-2937-2026
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S
- Class II
- Ongoing
Aug 19, 2026
Z-2936-2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
BioFire Diagnostics, LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2935-2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Straumann USA LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2934-2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
Waldemar Link GmbH & Co. KG (Mfg Site)
- Class II
- Ongoing
Aug 19, 2026
Z-2933-2026
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
OBP Medical Corporation
- Class II
- Ongoing
Aug 19, 2026
Z-2932-2026
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventiona…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Class II
- Ongoing
Aug 19, 2026
Z-2931-2026
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*,…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Class II
- Ongoing
Aug 19, 2026
Z-2930-2026
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the…
Terumo Medical Corporation
- Class II
- Ongoing
Aug 19, 2026
Z-2929-2026
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann USA LLC
- Class II
- Ongoing
Aug 19, 2026
Z-2928-2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Class II
- Ongoing
Aug 19, 2026
Z-2927-2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Remel Europe Ltd.
- Class II
- Ongoing
Aug 19, 2026
Z-2926-2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Industries, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2925-2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Industries, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2924-2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Industries, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2923-2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Medline Industries, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2922-2026
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Covidien, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2921-2026
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Covidien, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2920-2026
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Covidien, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2919-2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE…
Covidien, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2918-2026
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOC…
Covidien, LP
- Class II
- Ongoing
Aug 19, 2026
Z-2917-2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Rad…
Galt Medical Corporation
- Class II
- Ongoing
Aug 19, 2026
Z-2916-2026
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacel…
Spacelabs Healthcare, Inc.
- Class II
- Ongoing
Aug 19, 2026
Z-2915-2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
W L Gore & Associates, Inc.
- Class II
- Ongoing
Aug 19, 2026
Z-2914-2026
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
W L Gore & Associates, Inc.
- Class II
- Ongoing