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 110 of 1190
FDA device recalls, page 110 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0639-2025Class IIMEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-0638-2025Class IIMEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN...MEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-0637-2025Class IIMEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF...MEDLINE INDUSTRIES, LP - NorthfieldOJJ
Z-0636-2025Class IIMEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141BMEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-0635-2025Class IIRefer to RES or lead review memo for complete list of affected reference/catalog numbersMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0634-2025Class IIMEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-0633-2025Class IIMEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-0632-2025Class IIMEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-0631-2025Class IIMEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2)...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-0630-2025Class IIMEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3)...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-0629-2025Class IIMEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT...MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-0628-2025Class IIMEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-0627-2025Class IIMEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-0626-2025Class IIMEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-0625-2025Class IIMEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0624-2025Class IIMEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-0623-2025Class IIMEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-0622-2025Class IIMEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-0345-2025Class IIImed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made...The Metrix CompanyKPE
Z-0344-2025Class IIImed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made...The Metrix CompanyKPE
Z-0343-2025Class IIImed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made...The Metrix CompanyKPE
Z-0342-2025Class IIImed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made...The Metrix CompanyKPE
Z-0341-2025Class IISECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch...The Metrix CompanyKPE
Z-0340-2025Class IISECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made...The Metrix CompanyKPE
Z-0339-2025Class IISECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made...The Metrix CompanyKPE
Z-0338-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty...The Metrix CompanyKPE
Z-0337-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made...The Metrix CompanyKPE
Z-0336-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty...The Metrix CompanyKPE
Z-0335-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made...The Metrix CompanyKPE
Z-0334-2025Class IICORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch...The Metrix CompanyKPE
Z-0333-2025Class IICORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch...The Metrix CompanyKPE
Z-0332-2025Class IICORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch...The Metrix CompanyKPE
Z-0331-2025Class IIVYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch...The Metrix CompanyKPE
Z-0330-2025Class IIVYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch...The Metrix CompanyKPE
Z-0487-2025Class IIMONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use...Ethicon, IncGAN
Z-0347-2025Class IIApproach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part...Cook IncorporatedDQX
Z-0346-2025Class IIApproach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part...Cook IncorporatedDQX
Z-0921-2025Class IIDRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361DRG International, Inc.CFP
Z-0353-2025Class IIPhilips Zenition 70, Model Number: 718133Philips Medical Systems Nederland B.V.OWB
Z-0352-2025Class IIPhilips Zenition 50, Model Number: 718096Philips Medical Systems Nederland B.V.OWB
Z-0296-2025Class ILifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive...Respironics, Inc.CBK
Z-0295-2025Class IGarbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive...Respironics, Inc.CBK
Z-0294-2025Class IAeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation...Respironics, Inc.CBK
Z-0293-2025Class ITrilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B...Respironics, Inc.CBK
Z-0292-2025Class ITrilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and...Respironics, Inc.CBK
Z-0291-2025Class ITrilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B...Respironics, Inc.CBK
Z-0290-2025Class ITrilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B...Respironics, Inc.CBK
Z-0989-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics...Abbott MedicalMOM
Z-0988-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics...Abbott MedicalMOM
Z-0476-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723Hobbs Medical, Inc.FBK