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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 476 of 1191

FDA device recalls, page 476 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0826-2018	Class II	ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240	Tosoh Bioscience Inc	JLS	2018-02-13
Z-0825-2018	Class II	ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239	Tosoh Bioscience Inc	JLS	2018-02-13
Z-2661-2018	Class II	Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be...	Arjohuntleigh Magog, Inc.	FSA	2018-02-12
Z-2660-2018	Class II	Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be...	Arjohuntleigh Magog, Inc.	FSA	2018-02-12
Z-1626-2018	Class II	Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in...	Boston Scientific Corporation	PWI	2018-02-12
Z-1625-2018	Class II	PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in...	Boston Scientific Corporation	PWI	2018-02-12
Z-1624-2018	Class II	PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue...	Boston Scientific Corporation	PWI	2018-02-12
Z-1623-2018	Class II	Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in...	Boston Scientific Corporation	PWI	2018-02-12
Z-1622-2018	Class II	Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in...	Boston Scientific Corporation	PWI	2018-02-12
Z-1621-2018	Class II	Capio RP; Model #M0068321010. Intended for use in general suturing applications during...	Boston Scientific Corporation	PWI	2018-02-12
Z-1620-2018	Class II	Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general...	Boston Scientific Corporation	PWI	2018-02-12
Z-1619-2018	Class II	Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general...	Boston Scientific Corporation	PWI	2018-02-12
Z-1618-2018	Class II	Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of...	Boston Scientific Corporation	PWI	2018-02-12
Z-1617-2018	Class II	Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications...	Boston Scientific Corporation	PWI	2018-02-12
Z-1616-2018	Class II	Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general...	Boston Scientific Corporation	PWI	2018-02-12
Z-1274-2018	Class II	SporAmpule Biological Indicator Catalog Number SPS5-100	Mesa Laboratories Inc	FRC	2018-02-12
Z-1273-2018	Class II	ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471	Mesa Laboratories Inc	FRC	2018-02-12
Z-2926-2018	Class II	Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name...	Stanbio Laboratory	GKR	2018-02-08
Z-1773-2018	Class II	POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1772-2018	Class II	POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1771-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1770-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1769-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1768-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1767-2018	Class II	POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1766-2018	Class II	POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1765-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1764-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1763-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1762-2018	Class II	POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1761-2018	Class II	POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1760-2018	Class II	POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane...	Bard Peripheral Vascular Inc	LJT	2018-02-08
Z-1415-2018	Class II	Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1414-2018	Class II	IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1413-2018	Class II	Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1412-2018	Class II	Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1411-2018	Class II	Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray...	Philips North America LLC	JAK	2018-02-08
Z-1410-2018	Class II	Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray...	Philips North America LLC	JAK	2018-02-08
Z-1409-2018	Class II	Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1408-2018	Class II	Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1407-2018	Class II	Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1406-2018	Class II	Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1405-2018	Class II	Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1404-2018	Class II	Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product...	Philips North America LLC	JAK	2018-02-08
Z-1480-2018	Class II	Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No...	Life Technologies Corporation	PQP	2018-02-08
Z-1157-2018	Class II	J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF	Apyx Medical Corporation	GEI	2018-02-08
Z-1156-2018	Class II	J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR	Apyx Medical Corporation	GEI	2018-02-08
Z-1155-2018	Class II	J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B	Apyx Medical Corporation	GEI	2018-02-08
Z-1154-2018	Class II	J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N...	Apyx Medical Corporation	GEI	2018-02-08
Z-1153-2018	Class II	J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP...	Apyx Medical Corporation	GEI	2018-02-08