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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 363 of 1190

FDA device recalls, page 363 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1062-2020	Class II	Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY	Centurion Medical Products, LP	LRP	2019-12-11
Z-1061-2020	Class II	Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT...	Centurion Medical Products, LP	OXQ	2019-12-11
Z-1060-2020	Class II	Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT	Centurion Medical Products, LP	OIB	2019-12-11
Z-0923-2020	Class II	Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533...	Lumitex Medical Devices, Inc.	LBI	2019-12-11
Z-0884-2020	Class II	Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length...	Brasseler USA I, L.P.	HTY	2019-12-11
Z-1059-2020	Class II	Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1058-2020	Class II	Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1057-2020	Class II	Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1056-2020	Class II	Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM...	Centurion Medical Products, LP	PXP	2019-12-11
Z-1055-2020	Class II	Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC...	Centurion Medical Products, LP	MLT	2019-12-11
Z-1054-2020	Class II	Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1053-2020	Class II	Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1052-2020	Class II	Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1051-2020	Class II	Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION...	Centurion Medical Products, LP	OHG	2019-12-11
Z-1050-2020	Class II	Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY...	Centurion Medical Products, LP	MLT	2019-12-11
Z-1049-2020	Class II	Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE...	Centurion Medical Products, LP	OXQ	2019-12-11
Z-1048-2020	Class II	Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO...	Centurion Medical Products, LP	LRP	2019-12-11
Z-1047-2020	Class II	Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL...	Centurion Medical Products, LP	OXQ	2019-12-11
Z-1046-2020	Class II	Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690	Centurion Medical Products, LP	OFX	2019-12-11
Z-0810-2020	Class II	Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo...	Suntech Medical, Inc.	DXN	2019-12-11
Z-1045-2020	Class II	Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC...	Centurion Medical Products, LP	OFF	2019-12-11
Z-1044-2020	Class II	Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC...	Centurion Medical Products, LP	OFF	2019-12-11
Z-1043-2020	Class II	Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST...	Centurion Medical Products, LP	PYI	2019-12-11
Z-1042-2020	Class II	Centurion Circumsion Trays as follows: Kit Code Product...	Centurion Medical Products, LP	OHG	2019-12-11
Z-0999-2020	Class II	ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog...	Roche Diabetes Care, Inc.	NBW	2019-12-11
Z-0998-2020	Class II	Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring...	Roche Diabetes Care, Inc.	NBW	2019-12-11
Z-0997-2020	Class II	Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring...	Roche Diabetes Care, Inc.	NBW	2019-12-11
Z-1107-2020	Class II	VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit	bioMerieux, Inc.	LFY	2019-12-10
Z-0921-2020	Class II	ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring...	Datascope Corp.	JGS	2019-12-09
Z-0920-2020	Class II	BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas...	Datascope Corp.	JGS	2019-12-09
Z-0789-2020	Class II	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143...	Abbott Medical	DYB	2019-12-09
Z-0783-2020	Class II	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303	Abbott Medical	DYB	2019-12-09
Z-1618-2020	Class II	Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF...	Karl Storz Endoscopy-America, Inc.	EQN	2019-12-06
Z-0837-2020	Class II	Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2019-12-06
Z-2330-2020	Class II	Mazor X Surgical System Positioner Type II, REF: ASM0214-02	Medtronic Navigation, Inc	OLO	2019-12-05
Z-0780-2020	Class II	Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System...	Stryker Corp.	HRS	2019-12-05
Z-1792-2020	Class I	0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI...	Argon Medical Devices, Inc	DQX	2019-12-04
Z-1791-2020	Class I	0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI...	Argon Medical Devices, Inc	DQX	2019-12-04
Z-1712-2020	Class II	Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer	GE Healthcare	KGI	2019-12-03
Z-1711-2020	Class II	Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer	GE Healthcare	KGI	2019-12-03
Z-1710-2020	Class II	Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer	GE Healthcare	KGI	2019-12-03
Z-1709-2020	Class II	Lunar iDXA bone densitometer	GE Healthcare	KGI	2019-12-03
Z-0873-2020	Class II	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11...	Exactech, Inc.	PHX	2019-12-03
Z-0872-2020	Class II	Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07...	Exactech, Inc.	PHX	2019-12-03
Z-0867-2020	Class II	Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14...	Advanced Medical Optics, Inc.	LZP	2019-12-03
Z-0678-2020	Class II	Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device...	Maquet Cardiovascular Us Sales, LLC	KFM	2019-12-03
Z-0744-2022	Class II	PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006	3-D Matrix, Inc.	NHB	2019-12-02
Z-2427-2020	Class II	BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle...	Argon Medical Devices, Inc	KNW	2019-12-02
Z-0809-2020	Class II	Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number...	Degania Silicone, Inc.	EZL	2019-12-02
Z-0835-2020	Class II	Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying...	Polymer Technology Systems	NBW	2019-12-02