RECALL: MEDICAL DEVICE RECALL LISTING 2021

The list below contains Medical Device Recall for the year 2021. This list provides recall reporting information to MDA by establishment in accordance to requirement stipulated in Section 42, Act 737 and Regulation 7 and 8 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. Recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied and to notify its affected person of its defectiveness or potential defectiveness.

If you have experienced any safety and performance issue with one of the medical devices listed for Recall action, please seek advice from your healthcare professional as soon as possible.

MEDICAL DEVICE RECALL LISTING 2021

Date Received	Ref. No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
21/1/2021	MDA/PMSV/R2021-001	Voluntary Recall	Polypectomy Snares (Captiflex, Captivator, Captivator II, Profile, Sensation)	GB7742858216	Class II	A16 Protective Measures Problem	Boston Scientific (M) Sdn Bhd	MDA-1754-WDP121
25/1/2021	MDA/PMSV/R2021-002	Voluntary Recall	Revigance Lift Sterile PDO (Polydioxanone) Suture With Needle	GD10838319-27082	Class III	A04 Material Integrity Problem	AJ Research & Pharma Sdn. Bhd.	MDA-2480-WDP121
2/2/2021	MDA/PMSV/R2021-003	Voluntary Recall	Insulin Syringe	GB83427168517	Class II	A08 Calibration Problem	Ideal Healthcare Sdn Bhd	MDA-0003-KD314
3/2/2021	MDA/PMSV/R2021-004	Voluntary Recall	Tecnis Toric 1-Piece Acrylic Intraocular Lens	GC62178188817	Class III	A23 Use of Device Problem	Johnson & Johnson Sdn. Bhd.	MDA-0081-WDP415
15/2/2021	MDA/PMSV/R2021-005	Voluntary Recall	Valiant Navion™ Thoracic Stent Graft System	GD8644419-29954	Class I	A24 Adverse Event Without Identified Device or Use Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
18/2/2021	MDA/PMSV/R2021-006	Voluntary Recall	Alinity i HIV Ag/Ab Combo Calibrator	IVDD45413228618	Class I	A21 Labelling, Instructions for Use or Training Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
18/2/2021	MDA/PMSV/R2021-007	Voluntary Recall	Disposable Syringe 50 ml Luer Lock & Disposable Syringe 50 ml Luer Slip	GA8289892816	Class II	A18 Contimination/ decontimination problem	Muzamal Industries Sdn Bhd	MDA-0934-K120
22/2/2021	MDA/PMSV/R2021-008	Voluntary Recall	DC Bead™, DC Bead™ M1, and DC Bead LUMI™ Radiopaque Microspheres	GD5459620-41507	Class III	A21 Labelling, Instructions for Use or Training Problem	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
24/2/2021	MDA/PMSV/R2021-009	Voluntary Recall	Amicus Seperator	GC61175798418	Class II	A05 Mechanical Problem	Fresenius Kabi Malaysia Sdn. Bhd.	MDA-1185-WP120
25/2/2021	MDA/PMSV/R2021-010	Voluntary Recall	Triathlon Tritanium Tibial Component, Size 4	GD42222611618	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
26/2/2021	MDA/PMSV/R2021-011	Voluntary Recall	Implacross® PE Insert 10°Ø 28/35mm	GC5835819-32229	Class III	A04 Material Integrity Problem	Enrich Medsurg Sdn Bhd	MDA-1520-W120
27/2/2021	MDA/PMSV/R2021-012	Voluntary Recall	Thermo Scientific™ VersaTREK™ Automated Microbial detection System SBC Software 2.0.2.2	Special access	Class III	A11 Computer Software Problem	Thermo Scientific Microbiology Sdn. Bhd.	KP9537878115
11/3/2021	MDA/PMSV/R2021-013	Voluntary Recall	Surgiwand II Suction And Irrigation Device	GB54028806418	Class II	A02 Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
11/3/2021	MDA/PMSV/R2021-014	Voluntary Recall	Arrow® OnConrol® Bone Lesion Biopsy System Tray	GB81172407517	Class II	A05 Mechanical Problem	Teleflex Medical Sdn Bhd	MDA-912-W78115
12/3/2021	MDA/PMSV/R2021-015	Voluntary Recall	Video processor/illuminator (VPI)	GB9703519-3597, GB9913119-35970	Class II	A11 Computer Software Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
18/3/2021	MDA/PMSV/R2021-016	Voluntary Recall	Gravity Infusion sets & connectors	GB98684803818 GMD5708728216A GB46910936618 GA12081131417	Class II	A04 Material Integrity Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
30/3/2021	MDA/PMSV/R2021-017	Voluntary Recall	Alcohol Swab	GA2186420-38592	Class III	A02 Manufacturing, Packaging or Shipping Problem	Sun Healthcare (M) Sdn Bhd	MDA-0526-K52619
30/3/2021	MDA/PMSV/R2021-018	Voluntary Recall	Tubing Set, Irrigation, PC	GC369381061518	Class III	A02 Manufacturing, Packaging or Shipping Problem	UMMI Surgical Sdn Bhd	MDA-163-WDP7515
30/3/2021	MDA/PMSV/R2021-019	Voluntary Recall	HYSTEROMAT E.A.S.I.®	GC387141125118	Class III	A06 Output Problem	UMMI Surgical Sdn Bhd	MDA-163-WDP7515
30/3/2021	MDA/PMSV/R2021-020	Voluntary Recall	HYSTOACRYL BLUE 0.5ML	GD68903723118	Class III	A03 Chemical Problem	Apex Pharmacy Marketing Sdn Bhd	MDA-1201-WDP120
7/4/2021	MDA/PMSV/R2021-021	Voluntary Recall	ARCHITECT HBsAg Next Confirmatory Reagent Kit	IVDD3213419-36000	Class II	A09 Output Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
7/4/2021	MDA/PMSV/R2021-022	Voluntary Recall	Gunther Tulip® Vena Cava Filter Retrieval Set for Jugular Vein Approach (RPN: GTRS-200-RB)	GD997621116318	Class I	A02 Manufacturing, Packaging or Shipping Problem	Cook Asia (Malaysia) Sdn Bhd	MDA-497-WDP40015
8/4/2021	MDA/PMSV/R2021-023	Voluntary Recall	10mm x 32cm Regular (Vented) Suction Irrigator Tip 10mm x 32cm Pool Suction Irrigator Tip 5mm x 32cm Regular (Vented) Sution Irrigator Tip 5mm x 32cm Pool Suction Irrigator Tip 5mm x 33cm Monopolar Handle 5mm x 33cm Ratcheting Handle	GC182861046218, GC36399916518	Class III	A18 Contimination/ decontimination problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
7/4/2021	MDA/PMSV/R2021-024	Voluntary Recall	Resolution Clip Device	GC99352258317	Class III	A21 Labelling, Instructions for Use or Training Problem	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
14/4/2021	MDA/PMSV/R2021-025	Voluntary Recall	Gunther Tulip® Vena Cava Filter Retrieval Set for Jugular Vein Approach (RPN: GTRS-200-RB)	GD997621116318	Class III	A02 Manufacturing, Packaging or Shipping Problem	Syarikat Perniagaan Miscell Sdn. Bhd.	MDA-1642-DP121
19/4/2021	MDA/PMSV/R2021-026	Voluntary Recall	Omnia Soft Tissue Punch	GB26021446717	Class III	A02 Manufacturing, Packaging or Shipping Problem	Kavo Kerr Group Malaysia Sdn. Bhd.	MDA-818-D69815
20/4/2021	MDA/PMSV/R2021-027	Voluntary Recall	BD Microtainer EDTA Tubes	IVDB14372247818	Class III	A02 Manufacturing, Packaging or Shipping Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
22/4/2021	MDA/PMSV/R2021-028	Voluntary Recall	Eluvia Drug-Eluting Vascular Stent System	GD89855186317	Class III	A21 Labelling, Instructions for Use or Training Problem	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
3/5/2021	MDA/PMSV/R2021-029	Voluntary Recall	RUSCHELIT@ Super Safety Clear Tracheal Tube	GB87665877718	Class II	A05 Mechanical Problem	Teleflex Medical Sdn Bhd.	MDA-912-W78115
6/5/2021	MDA/PMSV/R2021-030	Voluntary Recall	ACUVUE® Vita® Brand Contact Lenses	GB73488352217	Class III	A02 Manufacturing, Packaging or Shipping Problem	Johnson & Johnson Sdn. Bhd.	MDA-0081-WDP415
6/5/2021	MDA/PMSV/R2021-031	Voluntary Recall	ARIES® HSV 1&2 Assay	IVDC44297287118	Class III	A02 Manufacturing, Packaging or Shipping Problem	DKSH Malaysia Sdn. Bhd.	MDA-0023-WDP2314
11/5/2021	MDA/PMSV/R2021-032	Voluntary Recall	BD Venflon Pro Safety Needle Protected I.V. Cannula	GB223681152118	Class III	A16 Protective Measures Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
17/5/2021	MDA/PMSV/R2021-033	Voluntary Recall	Synaptive™ Trackable Suction	GB10651620-44306	Class III	A05 Mechanical Problem	Transmedic Healthcare Sdn Bhd	MDA-096-WDP1815
18/5/2021	MDA/PMSV/R2021-034	Voluntary Recall	Mako Hip End Effector, Variable Angle	GC593731188118	Class III	A05 Mechanical Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
19/5/2021	MDA/PMSV/R2021-035	Voluntary Recall	ARCHITECT 2nd Generation Testosterone Reagent Kit	IVDB31560272718	Class III	A09 Output Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
21/5/2021	MDA/PMSV/R2021-036	Voluntary Recall	Video Mediastinoscope	GB5350019-30371	Class I	A02 Manufacturing, Packaging or Shipping Problem	UMMI Surgical Sdn Bhd	MDA-163-WDP7515
22/5/2021	MDA/PMSV/R2021-037	Voluntary Recall	Arrow® - FiberOptix™ Intra-Aortic Balloon (IAB) Catheter Kit Ultra 8 IAB (IAB-05840-U)	GD44414701118 & GD877091305219	Class III	A02 Manufacturing, Packaging or Shipping Problem	Teleflex Medical Sdn Bhd	MDA-912-W78115
27/5/2021	MDA/PMSV/R2021-038	Voluntary Recall	Filter,Insufflation	GC15073992218	Class II	A18 Contimination/ decontimination problem	UMMI Surgical Sdn Bhd	MDA-163-WDP7515
27/5/2021	MDA/PMSV/R2021-039	Voluntary Recall	Venovo Venous Stent System	GD3171320-44431	Class II	A02 Manufacturing, Packaging or Shipping Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
28/5/2021	MDA/PMSV/R2021-040	Voluntary Recall	Covidien DAR™ airway products	GA81947176117 GMD95474341017 GB64574504517 GB38078774718 GB25845805318 GB44241838118 GB26726858518 GB68839860018 GB24250871218 GB49821974018	Class III	A18 Contimination/ decontimination problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
31/5/2021	MDA/PMSV/R2021-041	Voluntary Recall	Sarns™ TCM II Cooling and Heating Systems	Orphan Medical Device	Class III	A18 Contimination/ decontimination problem	Terumo Malaysia Sdn. Bhd.	MDA-0794-WDP120
31/5/2021	MDA/PMSV/R2021-042	Voluntary Recall	Transport Stretcher Prime Series with 5th wheel Stretcher (26 inch) Prime X Series with 5th wheel stretcher option Prime Series with big wheel Stretcher (30 inch) Bed InTouch without Zoom motor Secure 3 MedSurg Bed S3 EX – 3005 Stretcher Chair ST1-X Transport Stretcher SV1 Electric Hospital Bed SV2 Electric Hospital Bed	GMD81312423118A GA3888881016 GA94134878118 GMD52758479818A GMD24596367817A GA6897520-38646 GMD56953688518A GMD24011639518A	Class III	A23 Use of Device Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
1/6/2021	MDA/PMSV/R2021-043	Voluntary Recall	ZNN CMN Nail Comingle	GC272951021218	Class III	A02 Manufacturing, Packaging or Shipping Problem	Zimmer Medical (M) Sdn Bhd	MDA-0074-WDP7419
2/6/2021	MDA/PMSV/R2021-044	Voluntary Recall	Accessory 924256 Stimloc Burr Hole Cover 17L	GD95662207017	Class II	A02 Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
3/6/2021	MDA/PMSV/R2021-045	Voluntary Recall	Palindrome RT Chronic Catheter Kit	GD45802388717	Class II	A21 Labelling, Instructions for Use or Training Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
4/6/2021	MDA/PMSV/R2021-046	Voluntary Recall	PD 3L EMPTY BAG SYSTEM II	GA3899376816	Class III	A02 Manufacturing, Packaging or Shipping Problem	Baxter Healthcare (Malaysia) Sdn. Bhd	MDA-1025-WDP120
9/6/2021	MDA/PMSV/R2021-047	Voluntary Recall	JELONET Paraffin Gauze Dressing	GB1368175916	Class III	A02 Manufacturing, Packaging or Shipping Problem	Smith & Nephew Healthcare Sdn Berhad	MDA-00350-WP3514
14/6/2021	MDA/PMSV/R2021-048	Voluntary Recall	CoreValve Evolut R System CoreValve Evolut Pro System	GD682501280619 GD93060896418	Class II	A05 Mechanical Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
18/6/2021	MDA/PMSV/R2021-049	Voluntary Recall	Bare Fiber Single Use Sterile	GB87163763218	Class II	A18 Contimination/ decontimination problem	Biolitec (M) Sdn Bhd	MDA-1470-WDP120
29/6/2021	MDA/PMSV/R2021-050	Voluntary Recall	EMBLEM S-ICD System	GD51274167517	Class III	A05 Mechanical Problem	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
11/6/2021	MDA/PMSV/R2021-051	Voluntary Recall	Trilogy 100 Trilogy 200 A-Series BiPAP A40 A-Series BiPAP A30	GC68672225217 GC35643583518	Class II	A04 Material Integrity Problem	Philips Malaysia Sdn Bhd	MDA-0061-WDP6114
11/6/2021	MDA/PMSV/R2021-052	Voluntary Recall	DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+ SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500	GC68672225217 GC35643583518	Class II	A04 Material Integrity Problem	Philips Malaysia Sdn Bhd	MDA-0061-WDP6114
17/6/2021	MDA/PMSV/R2021-053	Voluntary Recall	Custom-Pak: MAL-Basic Cataract Pack (THONEH)	GC91293930918	Class II	A02 Manufacturing, Packaging or Shipping Problem	Alcon Laboratories Sdn Bhd	MDA-2114-W121
1/7/2021	MDA/PMSV/R2021-054	Voluntary Recall	HIGHFLEX Basket	GB67531725318	Class II	A02 Manufacturing, Packaging or Shipping Problem	UMMI Surgical Sdn.Bhd	MDA-163-WDP7515
6/7/2021	MDA/PMSV/R2021-055	Voluntary Recall	TRIATHLON PRIM CEM FXD BPLT #7 (STRYKER TRIATHLON TOTAL KNEE REPLACEMENT SYSTEM)	GD42222611618	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
7/7/2021	MDA/PMSV/R2021-056	Voluntary Recall	Heartware Ventricular Assist System (HVAD)	GD74345985518	Class I	A05 Mechanical Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
8/7/2021	MDA/PMSV/R2021-057	Voluntary Recall	High Flex Baskets	GB67531725318	Class II	A02 Manufacturing, Packaging or Shipping Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
9/7/2021	MDA/PMSV/R2021-058	Voluntary Recall	Restoris MCK Femoral Trial Restoris MCK Patellofemoral Trial	GC593731188118 GC91928491317	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
21/7/2021	MDA/PMSV/R2021-059	Voluntary Recall	Frova Intubating Introducer (RPN: C-CAE-14.0-70-FI)	GD997621116318	Class II	A02 Manufacturing, Packaging or Shipping Problem	Cook Asia (Malaysia) Sdn Bhd	MDA-497-WDP40015
21/7/2021	MDA/PMSV/R2021-060	Voluntary Recall	Pipeline™ Flex Embolization Device Pipeline™ Flex Embolization Device with Shield Technology™	GD99434203317 GD24104495317	Class II	A02 Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
22/7/2021	MDA/PMSV/R2021-061	Voluntary Recall	HARMONIC HD 1000I SHEARS 20CM SHAFT HARMONIC HD 1000I SHEARS 36CM SHAFT	GC34335374217	Class II	A05 Mechanical Problem	Johnson & Johnson Sdn. Bhd.	MDA-0081-WDP415
27/7/2021	MDA/PMSV/R2021-062	Voluntary Recall	UNICORE (UNICORE, MEDAX FINE NEEDLE ASPIRATION, EPITHEASY )	GB71343205817	Class III	A02 Manufacturing, Packaging or Shipping Problem	Healthcare Solution Sdn Bhd	MDA-2161-W121
2/8/2021	MDA/PMSV/R2021-063	Voluntary Recall	Arcos Modular Revision System	GC281271021718	Class II	A02 Manufacturing, Packaging or Shipping Problem	Zimmer Medical (M) Sdn Bhd	MDA-0074-WDP7419
2/8/2021	MDA/PMSV/R2021-064	Voluntary Recall	DUODERM EXTRA THIN CGF DRESSING DUODERM™ CGF™ CONTROL GEL FORMULA DRESSING	GD37834215117 GD319161024618	Class III	A02 Manufacturing, Packaging or Shipping Problem	ConvaTec Malaysia Sdn Bhd	MDA-1913-W121
3/8/2021	MDA/PMSV/R2021-065	Voluntary Recall	PRISMAFLEX M100 SET	GC99624912318	Class III	A02 Manufacturing, Packaging or Shipping Problem	Baxter Healthcare (Malaysia) Sdn. Bhd	MDA-1025-WDP120
6/8/2021	MDA/PMSV/R2021-066	Voluntary Recall	STEELEX® STE SET	GC28167528118	Class III	A02 Manufacturing, Packaging or Shipping Problem	B. Braun Medical Supplies Sdn Bhd	MDA-0032-DP3214
12/8/2021	MDA/PMSV/R2021-067	Voluntary Recall	Percuflex Plus Ureteral Stent	GC72146322617	Class III	A02 Manufacturing, Packaging or Shipping Problem	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
20/8/2021	MDA/PMSV/R2021-068	Voluntary Recall	Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm	GB45267961418	Class II	A02 Manufacturing, Packaging or Shipping Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
23/8/2021	MDA/PMSV/R2021-069	Voluntary Recall	DLP Left Heart Vent Catheters	GB73074946118	Class II	A05 Mechanical Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
1/9/2021	MDA/PMSV/R2021-070	Voluntary Recall	Sterile Blade Single-Use Accessories	GB51997858318 GB58828845718	Class II	A05 Mechanical Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
6/9/2021	MDA/PMSV/R2021-071	Voluntary Recall	EcoGel 200/ MediChoice Ultrasound Gel	GMD78847317617A	Class III	A18 Contimination/ decontimination problem	Somedico Sdn. Bhd.	MDA-1824-WDP121
13/9/2021	MDA/PMSV/R2021-072	Voluntary Recall	10mm CPCS Distal Centralizers	GC67108823418	Class III	A04 Material Integrity Problem	Smith & Nephew Healthcare Sdn Berhad	MDA-00350-WP3514
24/9/2021	MDA/PMSV/R2021-073	Voluntary Recall	Ilizarov Wire Tensioner	GC43867914218	Class III	A02 Manufacturing, Packaging or Shipping Problem	Smith & Nephew Healthcare Sdn Berhad	MDA-00350-WP3514
29/9/2021	MDA/PMSV/R2021-074	Voluntary Recall	Sterile Blade Single-Use Accessories	GD997621116318	Class III	A16 Protective Measures Problem	Syarikat Perniagaan Miscell Sdn. Bhd.	MDA-1642-DP121
6/10/2021	MDA/PMSV/R2021-075	Voluntary Recall	FIVE S 3.5x65, sterile, for single use	GB5838321-52999	Class II	A02 Manufacturing, Packaging or Shipping Problem	UMMI Surgical Sdn Bhd	MDA-163-WDP7515
1/11/2021	MDA/PMSV/R2021-076	Field Corrective Action	Intravascular Temperature Management System (IVTM)	GD36871341117	Class I	A05 Mechanical Problem	Zoll Medical Malaysia Sdn. Bhd.	MDA-925-WDP79215
3/11/2021	MDA/PMSV/R2021-077	Voluntary Recall	Drill, AO small Gamma3® Ø4.2 x 300 mm	GC32996796918	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
3/11/2021	MDA/PMSV/R2021-078	Voluntary Recall	Lifespan Eptfe Vascular Graft	GD22268810218	Class III	A02 Manufacturing, Packaging or Shipping Problem	Nyprax Business Solutions	MDA-400-WDP30415
10/11/2021	MDA/PMSV/R2021-079	Voluntary Recall	28MM -4 LFIT V40 HEAD (6260-9-028) 22.2MM STD LFIT V40 HEAD (6260-9-122)	GC23592916318	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
12/11/2021	MDA/PMSV/R2021-080	Voluntary Recall	Avelle™ Negative Pressure Wound Therapy (NPWT) Pump22.2MM STD LFIT V40 HEAD (6260-9-122)	GC78842764418	Class III	A02 Manufacturing, Packaging or Shipping Problem	ConvaTec Malaysia Sdn Bhd	MDA-1913-W121
15/11/2021	MDA/PMSV/R2021-081	Voluntary Recall	ARCHITECT Trigger Solution	IVDA11021198618	Class III	A21 Labelling, Instructions for Use or Training Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
17/11/2021	MDA/PMSV/R2021-082	Voluntary Recall	3M Nexcare Tegaderm Transparent Dressing (H1626)	GB81651211117	Class III	A21 Labelling, Instructions for Use or Training Problem	Delfi Marketing Sdn. Bhd.	MDA-1077-WDP120
26/11/2021	MDA/PMSV/R2021-083	Voluntary Recall	DRILL FOR 5MM, 1.5 x 50MM, STRYKER-SHAFT	GC15618916118	Class III	A02 Manufacturing, Packaging or Shipping Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
13/12/2021	MDA/PMSV/R2021-084	Field Corrective Action	BD Vacutainer® ACD Solution A Blood Collection Tubes	IVDB34161212418	Class II	A02 Manufacturing, Packaging or Shipping Problem	Becton Dickinson Sdn Bhd	MDA-0033-W3314
16/12/2021	MDA/PMSV/R2021-085	Voluntary Recall	Dynetic‐35	GD5342320-50549	Class II	A18 Contimination/ decontimination problem	Biotronik Medical Devices (Malaysia) Sdn. Bhd	MDA-2134-WDP121
20/12/2021	MDA/PMSV/R2021-086	Voluntary Recall	Multichem WBT	IVDC53568227818	Class III	A21 Labelling, Instructions for Use or Training Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
20/12/2021	MDA/PMSV/R2021-087	Voluntary Recall	VIZADISC Hip Procedure Tracking Kit VIZADISC Knee Procedure Tracking Kit	GC593731188118	Class III	A21 Labelling, Instructions for Use or Training Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
23/12/2021	MDA/PMSV/R2021-088	Voluntary Recall	NIM TriVantage EMG Endotracheal Tube NIM-Neuro 3.0 System and Accessories	GB91582260417 GB45802845818	Class II	A02 Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
22/12/2021	MDA/PMSV/R2021-089	Voluntary Recall	Disposable Subdermal Corkscrew Needle Electrode	GB748191272819	Class III	A21 Labelling, Instructions for Use or Training Problem	Abbott Laboratories (M) Sdn. Bhd.	MDA-1685-W121
23/12/2021	MDA/PMSV/R2021-090	Voluntary Recall	All non-implanted Oticon Medical Neuro Zti EVO implants with a serial number from NZB04074 and above, All non-implanted Oticon Medical Neuro Zti CLA implants with a serial number from NZA02454 and above.	GD71157688718	Class III	A17 Compatibility Problem	Demant Malaysia Sdn. Bhd.	MDA-1624-WDP121
27/12/2021	MDA/PMSV/R20 21-091	Voluntary Recall	Endurant II and Endurant IIS Stent Graft System	GD23961629218	Class II	A02 Manufacturing, Packaging or Shipping Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414

* The information contained in the Medical Device Authority Recall database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.

Post Market Surveillance & Vigilance Unit

Medical Device Authority,
Ministry of Health Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya,

Selangor, MALAYSIA.

Off. No: +603-8230 0300
Fax. No: +603-8230 0200