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 93 of 1190
FDA device recalls, page 93 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1329-2025Class IIZ1 Femoral Hip System, Product Number 611777612Zimmer GmbHLZO
Z-1395-2025Class IIZebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold...Remel IncLRG
Z-1296-2025Class IIBD BBL TB Stain Kit K, Catalog (REF): 212522Becton Dickinson & CoJTS
Z-1453-2025Class IIMedline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700...MEDLINE INDUSTRIES, LP - NorthfieldHRX
Z-1452-2025Class IIMedline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-1451-2025Class IIMedline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1450-2025Class IIMedline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-1449-2025Class IIMedline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-1448-2025Class IIMedline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-1447-2025Class IIMedline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1446-2025Class IIMedline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-1445-2025Class IIMedline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328BMEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1444-2025Class IIMedline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1443-2025Class IIMedline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-1442-2025Class IIMedline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673GMEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-1441-2025Class IIMedline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1440-2025Class IIMedline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1439-2025Class IIMedline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1438-2025Class IIMedline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1437-2025Class IIMedline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1436-2025Class IIMedline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1435-2025Class IIMedline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-1465-2025Class IIMedline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1464-2025Class IIMedline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1463-2025Class IIMedline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALSMEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1462-2025Class IIMedline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1461-2025Class IIMedline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1394-2025Class IIMedline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLCMEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1393-2025Class IIMedline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-1407-2025Class IISynapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010...FUJIFILM Healthcare Americas CorporationLLZ
Z-1389-2025Class IICandida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens...IMMY, Inc.GMI
Z-1293-2025Class IIAlcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09...Alcon LaboratoriesLRO
Z-1392-2025Class IIOrigin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1Brainlab, Inc.LLZ
Z-2149-2025Class IIBodor's I series laser cutting machine.Jinan Bodor Cnc Machine Co LtdRFE
Z-1330-2025Class IIVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding...Cordis US Corp.DQY
Z-1307-2025Class IICardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It...CardioFocus, Inc.OAE
Z-1362-2025Class IIVEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03American Contract Systems, Inc.OEZ
Z-1361-2025Class IITHORACIC PACK , Model No UTTC82Y UTTC82AA-01American Contract Systems, Inc.OEZ
Z-1360-2025Class IISPINE LUMBAR PACK , Model No UTSL72AA UTSL72ABAmerican Contract Systems, Inc.OJG
Z-1359-2025Class IIOPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02American Contract Systems, Inc.OEZ
Z-1358-2025Class IIMAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02American Contract Systems, Inc.OEZ
Z-1357-2025Class IIGENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08American Contract Systems, Inc.LRO
Z-1356-2025Class IIAV FISTULA , Model No UTAV77TAmerican Contract Systems, Inc.OEZ
Z-1355-2025Class IINEURO IR TRAY , Model No WENI56JAmerican Contract Systems, Inc.OJG
Z-1354-2025Class IIDIAGNOSTIC NEURO IR TRAY , Model No WENE21American Contract Systems, Inc.OJG
Z-1353-2025Class IICV BASIC PUMP PACK , Model No WECV23DAmerican Contract Systems, Inc.OEZ
Z-1352-2025Class IILAPAROSCOPY PACK , Model No SFLA02A SFLA02BAmerican Contract Systems, Inc.FDE
Z-1351-2025Class IIEAR PACK , Model No SFEA12AAmerican Contract Systems, Inc.OGR
Z-1350-2025Class IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BAmerican Contract Systems, Inc.LRO
Z-1349-2025Class IILACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07BAmerican Contract Systems, Inc.LRO