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 2026-10-05, the FDA export date. FDA medical device recall database

59,336 records, page 1158 of 1187

FDA device recalls, page 1158 of 1187
Recall number	Product	Recalling firm	Product code	Initiated
Z-0363-04	ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual...	Abbott Medical	CGN--	2003-12-16
Z-0362-04	ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High...	Abbott Medical	CGN--	2003-12-16
Z-0361-04	ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials...	Abbott Medical	CGN--	2003-12-16
Z-0373-04	Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for...	Becton Dickinson & Co	GQG	2003-12-15
Z-0353-04	ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of...	Abbott Medical	CEC--	2003-12-15
Z-0328-04	Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...	Roche Diagnostics GmbH	JJE	2003-12-15
Z-0327-04	Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.	Roche Diagnostics GmbH	JJE	2003-12-15
Z-0326-04	Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.	Roche Diagnostics GmbH	JJE	2003-12-15
Z-0344-04	Invacare 2G Tarsys Seating System, Model 2GTR.	Invacare GmbH	ITI	2003-12-15
Z-0343-04	Invacare 2G Tarsys Seating System, Model 2GR.	Invacare GmbH	ITI	2003-12-15
Z-0342-04	Invacare 2G Tarsys Seating System, Model 2GT.	Invacare GmbH	ITI	2003-12-15
Z-0569-04	PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF #...	Abbott Medical	JOH	2003-12-12
Z-0505-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 25 mm; Product 903008025.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0504-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 20 mm; Product 903008020.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0503-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 15 mm; Product 903008015.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0502-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 10 mm; Product 903008010.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0501-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 5 mm; Product 903208005.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0500-04	Depuy brand ACE trochanteric nail end cap, non-sterile, 0 mm; Product 903008000.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0499-04	Depuy brand ACE trochanteric nail end cap, sterile, 25 mm; Product 903208025.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0498-04	Depuy brand ACE trochanteric nail end cap, sterile, 20 mm; Product 903208020.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0497-04	Depuy brand ACE trochanteric nail end cap, sterile, 15 mm; Product 903208015.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0496-04	Depuy brand ACE trochanteric nail end cap, sterile, 10 mm; Product 903208010.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0495-04	Depuy brand ACE trochanteric nail end cap, sterile, 5 mm; Product 903208005.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0494-04	Depuy brand ACE trochanteric nail end cap, sterile; Product 903208000.	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0493-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 100...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0492-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 95...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0491-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 90...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0490-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 85...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0489-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 80...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0488-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 75...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0487-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 70...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0346-04	Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile...	Medtronic, Inc.	HMX	2003-12-11
Z-0486-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 65...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0485-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 60...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0484-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 100 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0483-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 95 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0482-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 90 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0481-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 85 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0480-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 80 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0479-04	Depuy brand ACE trochanteric nail anti-rotation superior screw; sterile, 75 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0478-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 70 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0477-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 65 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0476-04	Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 60 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0475-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 120 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0474-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 115 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0473-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 110 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0472-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 105 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0471-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 100 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0470-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 95 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11
Z-0469-04	Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 90 mm; Product...	Depuy Orthopaedics Inc.	HSB	2003-12-11