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 322 of 1190

FDA device recalls, page 322 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0174-2021	Class II	MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0173-2021	Class II	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0172-2021	Class II	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0171-2021	Class II	HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0170-2021	Class II	HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0169-2021	Class II	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0168-2021	Class II	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0167-2021	Class II	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0166-2021	Class II	OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0165-2021	Class II	OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0164-2021	Class II	TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0163-2021	Class II	TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0162-2021	Class II	TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0161-2021	Class II	TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202620	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0160-2021	Class II	TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0159-2021	Class II	TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0158-2021	Class II	TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 72202610	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0157-2021	Class II	TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0156-2021	Class II	TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0155-2021	Class II	TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0154-2021	Class II	OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0153-2021	Class II	OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Number: 72201996	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0152-2021	Class II	OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0151-2021	Class II	OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0150-2021	Class II	OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0149-2021	Class II	OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0148-2021	Class II	OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0147-2021	Class II	RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Number: 72201805	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0146-2021	Class II	BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0145-2021	Class II	ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0144-2021	Class II	ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0143-2021	Class II	ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0142-2021	Class II	TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0141-2021	Class II	TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0140-2021	Class II	TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0139-2021	Class II	TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0138-2021	Class II	TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0137-2021	Class II	TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number...	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0136-2021	Class II	TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309	Smith & Nephew, Inc.	MAI	2020-09-09
Z-0135-2021	Class II	EMPOWR Acetabular System * EMPOWR Acetabular Cup, Cluster Hole, 54G * Size 54G 54 mm...	Encore Medical, LP	LPH	2020-09-09
Z-0116-2021	Class II	VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product...	Ethicon, Inc	GAM	2020-09-09
Z-0291-2021	Class II	GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System	W. L. Gore & Associates, Inc.	MIH	2020-09-09
Z-0290-2021	Class II	GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System	W. L. Gore & Associates, Inc.	MIH	2020-09-09
Z-1448-2022	Class II	AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM...	Aesculap Inc	NKB	2020-09-08
Z-1447-2022	Class II	AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM...	Aesculap Inc	NKB	2020-09-08
Z-1446-2022	Class II	AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM...	Aesculap Inc	NKB	2020-09-08
Z-1445-2022	Class II	AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code...	Aesculap Inc	NKB	2020-09-08
Z-1444-2022	Class II	AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code...	Aesculap Inc	NKB	2020-09-08
Z-1443-2022	Class II	AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code...	Aesculap Inc	NKB	2020-09-08
Z-0100-2021	Class II	MediCult Vitrification Cooling Media, Model Number 12284001F	CooperSurgical, Inc.	MQL	2020-09-08