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 310 of 1190

FDA device recalls, page 310 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0761-2021	Class II	BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of...	Becton Dickinson & Co	LON	2020-12-08
Z-0760-2021	Class II	BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of...	Becton Dickinson & Co	LON	2020-12-08
Z-0759-2021	Class II	BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of...	Becton Dickinson & Co	LON	2020-12-08
Z-1521-2021	Class II	Grace Medical REF S-4500 * spineX BONE DUST COLLECTOR * 2 stainless steel filters...	Oto Med Inc	MXP	2020-12-07
Z-1520-2021	Class II	Grace Medical REF S-3500 * COX BONE DUST COLLECTOR * 2 stainless steel filters...	Oto Med Inc	MXP	2020-12-07
Z-1519-2021	Class II	Grace Medical REF S-2500 * SHEEHY BONE DUST COLLECTOR * Stainless steel filter...	Oto Med Inc	MXP	2020-12-07
Z-1133-2021	Class II	IOLMaster 700	Carl Zeiss Meditec Inc	HJO	2020-12-07
Z-0847-2021	Class II	visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection...	Visby Medical, Inc.	QJR	2020-12-05
Z-1502-2021	Class II	Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product...	Medela AG	BTA	2020-12-02
Z-0958-2021	Class II	154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The...	Abbott Medical	FMG	2020-12-02
Z-0957-2021	Class II	7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The...	Abbott Medical	FMG	2020-12-02
Z-0956-2021	Class II	60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave Clear, 1.2 Micron Filter, 2...	Abbott Medical	FMG	2020-12-02
Z-0955-2021	Class II	60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage...	Abbott Medical	FMG	2020-12-02
Z-0863-2021	Class II	Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product...	Siemens Healthcare Diagnostics Inc.	JJE	2020-12-02
Z-0862-2021	Class II	Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product...	Siemens Healthcare Diagnostics Inc.	JJE	2020-12-02
Z-0861-2021	Class II	Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product...	Siemens Healthcare Diagnostics Inc.	JGS	2020-12-02
Z-0804-2021	Class II	CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for...	Roche Diagnostics GmbH	GJS	2020-12-02
Z-0803-2021	Class II	CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for...	Roche Diagnostics GmbH	GJS	2020-12-02
Z-0799-2021	Class II	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0798-2021	Class II	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0797-2021	Class II	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0796-2021	Class II	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0795-2021	Class II	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0794-2021	Class II	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0793-2021	Class II	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0792-2021	Class II	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0791-2021	Class II	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model...	STERIS Corporation	FRG	2020-12-02
Z-0790-2021	Class II	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per...	STERIS Corporation	FRG	2020-12-02
Z-0789-2021	Class II	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6...	STERIS Corporation	FRG	2020-12-02
Z-0788-2021	Class II	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10...	STERIS Corporation	FRG	2020-12-02
Z-0787-2021	Class II	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per case 10...	STERIS Corporation	FRG	2020-12-02
Z-0786-2021	Class II	Vis-U-All High Temperature Tubing 3"x100'. One roll per box; 10 boxes per case 10...	STERIS Corporation	FRG	2020-12-02
Z-0951-2021	Class I	EMBLEM MRI S-ICD Model A219	Boston Scientific Corporation	LWS	2020-12-02
Z-0950-2021	Class I	EMBLEM S-ICD Model A209	Boston Scientific Corporation	LWS	2020-12-02
Z-0936-2021	Class II	EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219	Boston Scientific Corporation	LWS	2020-12-02
Z-0935-2021	Class II	EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209	Boston Scientific Corporation	LWS	2020-12-02
Z-0720-2021	Class II	MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial...	Siemens Healthcare Diagnostics Inc.	LRG	2020-12-02
Z-0723-2021	Class II	Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for...	Zimmer GmbH	JWH	2020-12-01
Z-0778-2021	Class II	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN...	Boston Scientific Corporation	PCU	2020-12-01
Z-0777-2021	Class II	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN...	Boston Scientific Corporation	PCU	2020-12-01
Z-0776-2021	Class II	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN...	Boston Scientific Corporation	PCU	2020-12-01
Z-0775-2021	Class II	AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660...	Boston Scientific Corporation	PCU	2020-12-01
Z-0774-2021	Class II	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650...	Boston Scientific Corporation	PCU	2020-12-01
Z-0773-2021	Class II	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640...	Boston Scientific Corporation	PCU	2020-12-01
Z-0656-2021	Class II	Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno	Siemens Medical Solutions USA, Inc.	OWB	2020-11-30
Z-0631-2021	Class II	RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230...	Zimmer GmbH	HTW	2020-11-25
Z-0630-2021	Class II	Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.	Zimmer GmbH	MBI	2020-11-25
Z-0629-2021	Class II	Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product...	Zimmer GmbH	JEY	2020-11-25
Z-0628-2021	Class II	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage...	Zimmer GmbH	MEH	2020-11-25
Z-0627-2021	Class II	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534...	Zimmer GmbH	LPH	2020-11-25