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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 593 of 1191

FDA device recalls, page 593 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1984-2016	Class II	BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440...	Boston Scientific Corporation	LJS	2016-03-14
Z-1983-2016	Class II	BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 &...	Boston Scientific Corporation	LJS	2016-03-14
Z-1982-2016	Class II	BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 &...	Boston Scientific Corporation	LJS	2016-03-14
Z-1981-2016	Class II	BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410...	Boston Scientific Corporation	LJS	2016-03-14
Z-1980-2016	Class II	Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN...	Boston Scientific Corporation	LJS	2016-03-14
Z-1979-2016	Class II	Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN...	Boston Scientific Corporation	LJS	2016-03-14
Z-1978-2016	Class II	Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 &...	Boston Scientific Corporation	LJS	2016-03-14
Z-1977-2016	Class II	Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx...	Boston Scientific Corporation	LJS	2016-03-14
Z-1976-2016	Class II	Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440...	Boston Scientific Corporation	LJS	2016-03-14
Z-1975-2016	Class II	Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420...	Boston Scientific Corporation	LJS	2016-03-14
Z-1974-2016	Class II	Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The...	Boston Scientific Corporation	LJS	2016-03-14
Z-1973-2016	Class II	Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The...	Boston Scientific Corporation	LJS	2016-03-14
Z-1972-2016	Class II	Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN...	Boston Scientific Corporation	LJS	2016-03-14
Z-1971-2016	Class II	Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910...	Boston Scientific Corporation	LJS	2016-03-14
Z-1970-2016	Class II	Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx...	Boston Scientific Corporation	LJS	2016-03-14
Z-1969-2016	Class II	Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx...	Boston Scientific Corporation	LJS	2016-03-14
Z-1968-2016	Class II	Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx...	Boston Scientific Corporation	LJS	2016-03-14
Z-1515-2016	Class II	Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1514-2016	Class II	Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1513-2016	Class II	Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1512-2016	Class II	Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1511-2016	Class II	Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1510-2016	Class II	Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the...	Ossur Iceland ehf.	KQZ	2016-03-14
Z-1967-2016	Class II	Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560...	Boston Scientific Corporation	LJS	2016-03-14
Z-1966-2016	Class II	Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx...	Boston Scientific Corporation	LJS	2016-03-14
Z-1250-2016	Class II	CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas...	Terumo Cardiovascular Systems Corporation	DRY	2016-03-14
Z-2106-2018	Class III	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number...	Datascope Corp.	DWE	2016-03-11
Z-2105-2018	Class III	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part...	Datascope Corp.	DWE	2016-03-11
Z-2104-2018	Class III	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588	Datascope Corp.	DWE	2016-03-11
Z-1841-2016	Class II	Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical...	Miltex, Inc.	GDZ	2016-03-11
Z-2777-2016	Class II	Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed...	Integra LifeSciences Corporation	MDD	2016-03-11
Z-1834-2016	Class II	Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use...	MicroAire Surgical Instruments, LLC	GET	2016-03-11
Z-1551-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1550-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1549-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1548-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1547-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1546-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1545-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1544-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1543-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1542-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1541-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1540-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1539-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1538-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1537-2016	Class II	TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000...	Smith & Nephew, Inc.	JWH	2016-03-11
Z-1282-2016	Class II	Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system...	Siemens Medical Solutions USA, Inc.	OWB	2016-03-11
Z-1584-2016	Class II	Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl...	Research Instruments Ltd	MQJ	2016-03-11
Z-2707-2017	Class II	The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major...	Merge Healthcare Incorporated	DQK	2016-03-10