Department of Health | Medical Device Division - Surgical Masks and Respirators (NOT Listed Under MDACS)

Safety Alert Summary

Starting from 1 January 2022, the summary includes some safety alerts related to medical devices not listed under MDACS reported by the trade, other regulatory jurisdictions as well as the World Health Organization. It only serves as a reference and should not be considered as exhaustive and up-to-date information. Please contact manufacturer or local supplier for details. (Updated on 30 Oct 2024)

Caption: Data Table
Posting Date	Description of Product	Source of Information *
30 Oct 2024	30 Oct 2024北京中北博健科貿有限公司醫用外科口罩 [涉及産品型號、規格: 17cm x 17cm; 識別信息(如批號): 20240112]	30 Oct 2024Beijing Municipal MPA
16 Sep 2024	16 Sep 2024佛山市順德區康正衛生材料有限公司醫用外科口罩	16 Sep 2024Guangdong MPA
05 Aug 2024	05 Aug 2024Ridgeback Logistics Mahoma Pro Protective Face Mask, 4 Ply Mask	05 Aug 2024TGA
05 Aug 2024	05 Aug 2024Sydicare Pty Ltd K-Boxing - Disposable medical face mask - Type IIR [Batch number: 2020092801]	05 Aug 2024TGA
02 Aug 2024	02 Aug 2024KCM Hygiene Pty Ltd Mask, Surgical, Single Use	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024J & K Trading Pty Ltd Mask, Surgical, Single Use	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Ideal Corporate Accessories Mask, Surgical, Reusable	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Hui Cheng International Pty Ltd Mask, Surgical, Single Use	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Bodyment Bodyment - BodyAid KN95	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Youpin Australia Pty Ltd Public N95 Respirator	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Youpin Australia Pty Ltd Mask, Surgical, Single Use	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024VNA Technology Pty Ltd Mask, Surgical, Single Use	02 Aug 2024TGA
02 Aug 2024	02 Aug 2024Surf Coast PPE Public N95 Respirator	02 Aug 2024TGA
11 Mar 2024	11 Mar 2024Bruder Healthcare Company Thermalon Sinus Mask	11 Mar 2024Health Canada
19 Feb 2024	19 Feb 2024AMD Medicom Inc. HENRY SCHEIN EARLOOP MASKS LEVEL 3 (BLUE)	19 Feb 2024FDA
18 Dec 2023	18 Dec 2023廣東名立醫療科技有限公司一次性使用醫用口罩	18 Dec 2023Guangdong MPA
13 Dec 2023	13 Dec 2023北京朋來製藥有限公司醫用防護口罩	13 Dec 2023Beijing Municipal MPA
27 Nov 2023	27 Nov 2023廣東同德藥業有限公司一次性使用醫用口罩 [生産批號: 221106; 涉及産品的型號、規格及批次: 耳掛式 (17.5cm x 9.5cm)]	27 Nov 2023Guangdong MPA
03 Oct 2023	03 Oct 2023Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication	03 Oct 2023FDA
15 Sep 2023	15 Sep 2023廣東名立醫療科技有限公司醫用外科口罩及一次性使用醫用口罩 [醫用外科口罩，生産批號:20220802; 一次性使用醫用口罩，生産批號: 20220801; 20220705]	15 Sep 2023Guangdong MPA
11 Sep 2023	11 Sep 2023Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication	11 Sep 2023FDA
22 Aug 2023	22 Aug 2023O&M Halyard, Inc FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size Small (Code 46827, Lot #AM2164811)	22 Aug 2023生產商
18 Aug 2023	18 Aug 2023東莞市新山科技有限公司醫用外科口罩 [生産批號：20221025; 涉及產品型號、規格：耳掛式 17.5cm*9.5cm]	18 Aug 2023Guangdong MPA
24 Jul 2023	24 Jul 2023Med-Con Pty Ltd Surgical face Mask - Earloop Level 3 Barrier [Product Code: 170516; Batch numbers: 45880, 45884, 45889, 45896, 45900, 45903, 45958, 45962, 45968]	24 Jul 2023TGA
19 Jul 2023	19 Jul 2023Medispec Australia Pty Ltd Mask, Surgical, Single Use	19 Jul 2023TGA
19 Jun 2023	19 Jun 2023Aidacare Pty Ltd Single use, surgical, mask	19 Jun 2023TGA
22 May 2023	22 May 2023Shengquan (Australia) High-Tech Pty Ltd Shengquan FFP2 Particle Filtering Half Mask; Shengquan KN95 Particle Filtering Half Mask; Unlabelled - Shengquan Respirator	22 May 2023TGA
22 May 2023	22 May 2023Advanced Medical Devices (AMD) Pty Ltd Nano-Tech T4 Respirator - All Batches	22 May 2023TGA
27 Apr 2023	27 Apr 2023Guangzhou Biofil Air Purification Materials Co Ltd (Sponsored by Platinum Closing Pty Ltd) Biofil Level 3 Surgical Mask [Batch 202009F01]	27 Apr 2023TGA
13 Apr 2023	13 Apr 2023Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication	13 Apr 2023FDA
13 Apr 2023	13 Apr 2023Taxa International Pty Ltd Mask, single use, surgical	13 Apr 2023TGA
13 Apr 2023	13 Apr 2023Medihealth Guard Facemask Pty Ltd Mask, surgical, single use	13 Apr 2023TGA
13 Apr 2023	13 Apr 2023Moosh (Australia) Pty Ltd Public respirator, single-use	13 Apr 2023TGA
13 Apr 2023	13 Apr 2023LYL Investment Pty Ltd Public Respirator, Single use	13 Apr 2023TGA
13 Apr 2023	13 Apr 2023ASPEN MEDICAL PTY LIMITED Public respirator, single use	13 Apr 2023TGA
13 Apr 2023	13 Apr 2023Jiangxi Longteng Biological High-Tech Co Ltd (Sponsored by Sunry Health Management Pty Ltd) Mask, surgical, single use	13 Apr 2023TGA
06 Apr 2023	06 Apr 2023Arya Mobility Pty Ltd Mask, surgical, single use [Batch: 20200318]	06 Apr 2023TGA
04 Apr 2023	04 Apr 2023Aidacare Pty Ltd Public respirator, single use	04 Apr 2023TGA
27 Mar 2023	27 Mar 2023AMPEQ Pty Ltd Public face mask, reusable	27 Mar 2023TGA
27 Mar 2023	27 Mar 2023Life Biotech Pty Ltd Public N95 respirator	27 Mar 2023TGA
27 Mar 2023	27 Mar 2023Maroon Tree Pty Ltd Mask, surgical, single use; Medical/Surgical Mask	27 Mar 2023TGA
27 Mar 2023	27 Mar 2023TLC Diagnostics Pty Ltd Mask, surgical, single-use	27 Mar 2023TGA
27 Mar 2023	27 Mar 2023Big Start Pty Ltd Big Start, Single use surgical mask [Batches: 200730, 200310 & 230320]	27 Mar 2023TGA
16 Mar 2023	16 Mar 2023Eagle Health Holdings Limited Eagle Health Holdings Ltd mask, surgical, single use	16 Mar 2023TGA
16 Mar 2023	16 Mar 2023HB Access Pty Ltd HB Access Pty Ltd mask, surgical, single use	16 Mar 2023TGA
14 Mar 2023	14 Mar 2023Oscar Wylee Pty Ltd mask, single use, surgical	14 Mar 2023TGA
14 Mar 2023	14 Mar 2023Mednow Pty Ltd mask, surgical, single use	14 Mar 2023TGA
02 Mar 2023	02 Mar 2023Schiffa Health Pty Ltd Schiffa Health Pty Ltd - mask, surgical, single use	02 Mar 2023TGA
10 Feb 2023	10 Feb 2023Health One Pty Ltd Health One Surgical Face Mask with Eye Shield Anti-fog, Anti-splash [Batch: S2020-29501, S2020-36501, S2020-36502, S2020-36503; Expiry: 14/08/2025, 30/10/2025, 12/11/2025, 24/11/2025]	10 Feb 2023TGA
06 Jan 2023	06 Jan 2023EMCHON PTY LTD Medical Surgical Mask	06 Jan 2023TGA
21 Dec 2022	21 Dec 2022Ironbark Creek Investments KN95 respirators supplied by Ironbark Creek Investments [Product names (as shown on packaging / labelling): Medilogic KN95 Face mask, CX9100 Particulate Mask FFP2 NR, Medilogic KN95 Face mask Box 10, Zhongchen KN95 Face Mask, Zhongchen KN95 Face Mask Non-Surgical, YiHuB KN95 Protective Mask; All batches of the above respirators within expiry]	21 Dec 2022TGA
16 Dec 2022	16 Dec 2022Orthotic & Prosthetic Centre Pty Ltd OAPL FACE MASK DISPOSABLE 3PLY EARLOOP [Batch number: 205029; Date of manufacture: 05/2020]	16 Dec 2022TGA
13 Dec 2022	13 Dec 2022Orthotic & Prosthetic Centre Pty Ltd OAPL Protective Face Mask with Earloops KN95 Mask 4PLY EAR LOOP [Batch number: 202004-9]	13 Dec 2022TGA
05 Dec 2022	05 Dec 2022Mun Global Sdn Bhd PrimeOn Artemis Level 2 Procedure Face Mask w/Earloop - Yellow [Lot number: 2004-09]	05 Dec 2022TGA
30 Nov 2022	30 Nov 2022BSN Medical (Aust) Pty Ltd Proshield Level 2 & 3 Surgical Masks and Proshield N95 Respirators [Batch numbers: All batches from OCT17; Proshield Resistant Surgical Masks; Batch numbers: All batches from OCT17 with logos only]	30 Nov 2022TGA
18 Aug 2022	18 Aug 2022Xiantao S&J Protective Products Co Ltd (Sponsored by SWISS MADE BRANDS PTY LTD) D-Touch Disposable Medical Facemasks [All D-Touch Disposable Medical Facemasks manufactured prior to 06-May-2022; D-Touch Disposable Medical Facemask with Elastic Bands, Batch / Expiry: 202003 / Mar-23, 202004 / Apr-23; D-Touch Disposable Medical Facemask with Tie-on, Batch / Expiry: 202010 / Oct-23]	18 Aug 2022TGA
12 Jul 2022	12 Jul 2022Canggu Medical Tech Co Ltd (Sponsored by PACIFIC HEALTH PTY LTD) Dochem Face Mask and Dochem Face Mask Type IIR [All Batches]	12 Jul 2022TGA
14 Jun 2022	14 Jun 2022Jiangsu Okam New Materials Ltd KN95/FFP2 Particulate Respirator Mask [Model 516W]	14 Jun 2022Health Canada
06 Jun 2022	06 Jun 2022Medical Mart Supplies Limited Alliance Earloop Procedure Mask [Lot or serial number: Y591676; Model or catalog number: P703020]	06 Jun 2022Health Canada
26 May 2022	26 May 2022BUNZL Australasia N95 Particulate Respirator N95 FT-N058 [All batches]	26 May 2022TGA
10 May 2022	10 May 2022Thai Hospital Products Co Ltd (Sponsored by Thermo Fisher Scientific Australia Pty Ltd) Promed Level 1 surgical face masks with ties, Promed Level 1 surgical face masks with Ear loops [Product reference code: PMD 4501 and PMD 4001; Batch numbers: 16-Sep-20 and 25-Aug-20]	10 May 2022TGA
03 May 2022	03 May 2022Mediquip Pty Ltd Gemini Dispoable Surgical Masks [Batch number: 2020072801; Expiry date: 28/07/2022]	03 May 2022TGA
03 May 2022	03 May 2022Purist Australian Purist Australian - Mask, medical single use [Batch number: 202003015; Production Date: 17/04/2020]	03 May 2022TGA
06 Apr 2022	06 Apr 2022Omni-Tel Pty Ltd MA-KN95-WOO [Batch numbers: QU201 and QU202; Expiry date: 05/2022 and 06/2022]	06 Apr 2022TGA
30 Mar 2022	30 Mar 2022MIRATRA PTY LTD GeeeF Disposable Medical Mask [Batch number: 06013; Expiry date: 13/07/2022], Disposable Medical Mask [Batch number: 202004008; Expiry date: 10/06/2022]	30 Mar 2022TGA
30 Mar 2022	30 Mar 2022MIRATRA PTY LTD Moosh P2 Respirator Mask [Batch Number: 202004008; Expiry Date: 09/2022]	30 Mar 2022TGA
09 Mar 2022	09 Mar 2022Sichuan Xinglin Medical Device Co Ltd/ Jin Pin Electrical Co Ltd Zhuhai SEZ (Sponsored by Australian Business Mobiles (NSW) Pty Ltd) Beare Medical Face Mask for Single Use - Level 2 Barrier - BMD 2 [Batch number: 26042020 and JP20200606; Expiry date: 30/04/2022 and 31/06/2022]	09 Mar 2022TGA
09 Mar 2022	09 Mar 2022BSN Medical (Aust) Pty Ltd Proshield Duckbill Fluid Resistant, Proshield Resistant, Proshield Clearview, Proshield Elite Visor Mask, Proshield Elite Antifog Mask, Proshield Elite Pleated Mask and Proshield Super Resistant Antifog Mask [Product codes: 72509-00,72509-04,72509-11,72509-19, 72509-20, 72509-21 and 72509-23; Batch numbers: 26Oct17, 39642 1, 18Sep20, 10Aug17, 29Jun20, 06Oct20 and 14Oct20]	09 Mar 2022TGA
08 Mar 2022	08 Mar 2022Sentry Medical Pty Ltd OWear Mask with Earloop Fluid Protection IIR-120 mmHg [Batch number: 043020; Expiry date: 1/04/2025]	08 Mar 2022TGA
08 Mar 2022	08 Mar 2022Pacific Health Pty Ltd Premium Ear-loop-3 Layers Masks [Batch number: WHM-1050]	08 Mar 2022TGA
08 Mar 2022	08 Mar 2022Sentry Medical Pty Ltd OWear Procedure Mask – Earloop OMK001 Level 2 [Batch number: 12008810F, Expiry date: 31 August 2023]	08 Mar 2022TGA
02 Mar 2022	02 Mar 2022Arya Mobility Pty Ltd Ripe KN95 Nanofiber filtration Anti-Particulate Anti-virus Mask [Batch number: 2020-03-30]	02 Mar 2022TGA
28 Feb 2022	28 Feb 2022MCG ELECTRONICS PTY LTD Ripe Doctors KN95 Airway protection face mask	28 Feb 2022TGA
21 Feb 2022	21 Feb 2022O&M Halyard Australia Pty Ltd Halyard Surgical Mask [Product code 6000; Batch number TH 02161644] & Halyard Procedure Mask [Product code 6001; Batch number TH 00321547]	21 Feb 2022TGA
21 Feb 2022	21 Feb 2022Icon International Pty Ltd t/a Icon Medipharm 3 PLY DISPOSABLE SURGICAL FACE MASK [Batch number: AL091, Expiry date: 1/3/2025]	21 Feb 2022TGA
15 Feb 2022	15 Feb 2022Optimed Technologies Pty Ltd Veisha KN95 Mask [Batch number: 20040716]	15 Feb 2022TGA
11 Feb 2022	11 Feb 2022Southmedic Inc. Clearchoice Foam Face Shields [W84856, W85334, W85588, W85001; SMI3610, SMI3611]	11 Feb 2022Health Canada
04 Feb 2022	04 Feb 2022Care Essentials Pty Ltd Cocoon Respirator Masks [Regular size head band (MSK-002): All batches with expiry dates of May 2023 or prior; Small size, ear loop (MSK-001S): All batches with expiry dates of June 2023 or prior.]	04 Feb 2022TGA
04 Feb 2022	04 Feb 2022priMED Medical Products Inc PRIMASOFT SURGICAL MASK, TIE, SOFT, WHITE, PG4-2333 Batch: 0419HLP20; PRIMAGARD PROCEDURE MASK, EAR LOOPS, BLUE, PM4-306 Batch: 0426CLP20; PRIMED SURGICAL MASK, TIE, ANTI-FOG, BLUE, PM4-311 Batch: 0523DLP21; PRIMED PEDIATRIC MASK, EARLOOP, DINOSAUR PATTERN, PG4-1680 Batch: 0414HLP20	04 Feb 2022TGA
04 Feb 2022	04 Feb 2022Winner Medical Co Ltd (Sponsored by Healthscope Operations PTY LTD) Particulate Respirator FFP2 NR [Batch number: 200519; Expiry date: 31/05/2023]	04 Feb 2022TGA
04 Feb 2022	04 Feb 2022Healthy Apparel Company Ltd Medical Mask (Adult) [Model or Catalogue Number: ADL2CAGR; Lot or Serial Number: 01L2021A2, 05J2021A2, 09K2021A2, 12J2021A2, 24I2021A2, 18J2021A2, 26J2021A2, 02K2021A2, 17K2021A2, 24K2021A2]	04 Feb 2022Health Canada
31 Jan 2022	31 Jan 2022Qingdao Santec International Trade Co Ltd (sponsored by Erskine Products Pty Ltd) Piksters Shield Face Masks Level 3 [Batch number: SAN29904A]	31 Jan 2022TGA
31 Jan 2022	31 Jan 2022St John Ambulance Australia Inc St John Respirator Mask [Batch number: 20200501S0002; Expiry date: 10 May 2023]	31 Jan 2022TGA
21 Jan 2022	21 Jan 2022A Barcs & Co Nominees Pty Ltd Foldable Protective Earloop Mask KN95	21 Jan 2022TGA
11 Jan 2022	11 Jan 2022Bio Protect Bio Protect Disposable Surgical Face Mask 3 Ply with Earloop Level 2	11 Jan 2022TGA
10 Jan 2022	10 Jan 2022Mediquip Pty Ltd Gemini KN95 Protective Medical Masks [Batch Number: CY-20200519-1; Expiry Date: 19/05/2022]	10 Jan 2022TGA

Special Alerts

Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below.

No record found

Note:

^* FDA = Food and Drug Administration, United States of America;
  MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
  Health Canada = Health Canada, Canada;
  TGA = Therapeutic Goods Administration, Australia;
  HPRA = Health Products Regulatory Authority, Ireland;
  HSA = Health Sciences Authority, Singapore