510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 114 of 1190
FDA device recalls, page 114 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0403-2025Class IIHalyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0402-2025Class IIHalyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0401-2025Class IIHalyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0400-2025Class IIHalyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0399-2025Class IIHalyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0398-2025Class IIHalyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0397-2025Class IIHalyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0396-2025Class IIHalyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0395-2025Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0394-2025Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0393-2025Class IIHalyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0392-2025Class IIHalyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0391-2025Class IIHalyard KIT, SHOULDER - Medical convenience kits Model Number: ESJH014-06Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0390-2025Class IIHalyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0389-2025Class IIHalyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0388-2025Class IIHalyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0387-2025Class IIHalyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-0386-2025Class IIHalyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-0385-2025Class IIHalyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-0384-2025Class IIHalyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0383-2025Class IIHalyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0266-2025Class IIremel BactiDrop Acridine Orange, REF 21502, 50 per package.Remel IncJFO
Z-0092-2025Class IVasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500Maquet Cardiovascular LLCGEI
Z-0256-2025Class IISURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0255-2025Class IISURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are...Integra LifeSciences CorporationHBA
Z-0254-2025Class IISURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are...Integra LifeSciences CorporationHBA
Z-0253-2025Class IISURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0252-2025Class IISURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0251-2025Class IISURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0250-2025Class IISURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0249-2025Class IISURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0248-2025Class IISURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0247-2025Class IISURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0246-2025Class IISURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0245-2025Class IISURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0244-2025Class IISURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0243-2025Class IISURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0242-2025Class IISURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips...Integra LifeSciences CorporationHBA
Z-0241-2025Class IISURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0240-2025Class IISURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0239-2025Class IISURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0238-2025Class IISURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0237-2025Class IISURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0236-2025Class IISURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical...Integra LifeSciences CorporationHBA
Z-0235-2025Class IIMICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical...Integra LifeSciences CorporationHBA
Z-0483-2025Class IINovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total...Novosource, LLCLPH
Z-0257-2025Class IIChameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US)...Medtronic, Inc.LIT
Z-0218-2025Class IIBaxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386Baxter Healthcare CorporationJEA
Z-0217-2025Class IIBaxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385Baxter Healthcare CorporationJEA
Z-0216-2025Class IIBaxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083Baxter Healthcare CorporationJEA