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)
| Posting Date | Description of Product | Source of Information * |
|---|---|---|
| 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] | Beijing Municipal MPA |
| 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 | Guangdong MPA |
| 05 Aug 2024 | Ridgeback Logistics Mahoma Pro Protective Face Mask, 4 Ply Mask | TGA |
| 05 Aug 2024 | Sydicare Pty Ltd K-Boxing - Disposable medical face mask - Type IIR [Batch number: 2020092801] | TGA |
| 02 Aug 2024 | KCM Hygiene Pty Ltd Mask, Surgical, Single Use | TGA |
| 02 Aug 2024 | J & K Trading Pty Ltd Mask, Surgical, Single Use | TGA |
| 02 Aug 2024 | Ideal Corporate Accessories Mask, Surgical, Reusable | TGA |
| 02 Aug 2024 | Hui Cheng International Pty Ltd Mask, Surgical, Single Use | TGA |
| 02 Aug 2024 | Bodyment Bodyment - BodyAid KN95 | TGA |
| 02 Aug 2024 | Youpin Australia Pty Ltd Public N95 Respirator | TGA |
| 02 Aug 2024 | Youpin Australia Pty Ltd Mask, Surgical, Single Use | TGA |
| 02 Aug 2024 | VNA Technology Pty Ltd Mask, Surgical, Single Use | TGA |
| 02 Aug 2024 | Surf Coast PPE Public N95 Respirator | TGA |
| 11 Mar 2024 | Bruder Healthcare Company Thermalon Sinus Mask | Health Canada |
| 19 Feb 2024 | AMD Medicom Inc. HENRY SCHEIN EARLOOP MASKS LEVEL 3 (BLUE) | FDA |
| 18 Dec 2023 | 廣東名立醫療科技有限公司 一次性使用醫用口罩 | Guangdong MPA |
| 13 Dec 2023 | 北京朋來製藥有限公司 醫用防護口罩 | Beijing Municipal MPA |
| 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)] | Guangdong MPA |
| 03 Oct 2023 | Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication | FDA |
| 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] | Guangdong MPA |
| 11 Sep 2023 | Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication | FDA |
| 22 Aug 2023 | O&M Halyard, Inc FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size Small (Code 46827, Lot #AM2164811) | 生產商 |
| 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] | Guangdong MPA |
| 24 Jul 2023 | Med-Con Pty Ltd Surgical face Mask - Earloop Level 3 Barrier [Product Code: 170516; Batch numbers: 45880, 45884, 45889, 45896, 45900, 45903, 45958, 45962, 45968] | TGA |
| 19 Jul 2023 | Medispec Australia Pty Ltd Mask, Surgical, Single Use | TGA |
| 19 Jun 2023 | Aidacare Pty Ltd Single use, surgical, mask | TGA |
| 22 May 2023 | Shengquan (Australia) High-Tech Pty Ltd Shengquan FFP2 Particle Filtering Half Mask; Shengquan KN95 Particle Filtering Half Mask; Unlabelled - Shengquan Respirator | TGA |
| 22 May 2023 | Advanced Medical Devices (AMD) Pty Ltd Nano-Tech T4 Respirator - All Batches | TGA |
| 27 Apr 2023 | Guangzhou Biofil Air Purification Materials Co Ltd (Sponsored by Platinum Closing Pty Ltd) Biofil Level 3 Surgical Mask [Batch 202009F01] | TGA |
| 13 Apr 2023 | Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication | FDA |
| 13 Apr 2023 | Taxa International Pty Ltd Mask, single use, surgical | TGA |
| 13 Apr 2023 | Medihealth Guard Facemask Pty Ltd Mask, surgical, single use | TGA |
| 13 Apr 2023 | Moosh (Australia) Pty Ltd Public respirator, single-use | TGA |
| 13 Apr 2023 | LYL Investment Pty Ltd Public Respirator, Single use | TGA |
| 13 Apr 2023 | ASPEN MEDICAL PTY LIMITED Public respirator, single use | TGA |
| 13 Apr 2023 | Jiangxi Longteng Biological High-Tech Co Ltd (Sponsored by Sunry Health Management Pty Ltd) Mask, surgical, single use | TGA |
| 06 Apr 2023 | Arya Mobility Pty Ltd Mask, surgical, single use [Batch: 20200318] | TGA |
| 04 Apr 2023 | Aidacare Pty Ltd Public respirator, single use | TGA |
| 27 Mar 2023 | AMPEQ Pty Ltd Public face mask, reusable | TGA |
| 27 Mar 2023 | Life Biotech Pty Ltd Public N95 respirator | TGA |
| 27 Mar 2023 | Maroon Tree Pty Ltd Mask, surgical, single use; Medical/Surgical Mask | TGA |
| 27 Mar 2023 | TLC Diagnostics Pty Ltd Mask, surgical, single-use | TGA |
| 27 Mar 2023 | Big Start Pty Ltd Big Start, Single use surgical mask [Batches: 200730, 200310 & 230320] | TGA |
| 16 Mar 2023 | Eagle Health Holdings Limited Eagle Health Holdings Ltd mask, surgical, single use | TGA |
| 16 Mar 2023 | HB Access Pty Ltd HB Access Pty Ltd mask, surgical, single use | TGA |
| 14 Mar 2023 | Oscar Wylee Pty Ltd mask, single use, surgical | TGA |
| 14 Mar 2023 | Mednow Pty Ltd mask, surgical, single use | TGA |
| 02 Mar 2023 | Schiffa Health Pty Ltd Schiffa Health Pty Ltd - mask, surgical, single use | TGA |
| 10 Feb 2023 | Health 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] | TGA |
| 06 Jan 2023 | EMCHON PTY LTD Medical Surgical Mask | TGA |
| 21 Dec 2022 | Ironbark 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] | TGA |
| 16 Dec 2022 | Orthotic & Prosthetic Centre Pty Ltd OAPL FACE MASK DISPOSABLE 3PLY EARLOOP [Batch number: 205029; Date of manufacture: 05/2020] | TGA |
| 13 Dec 2022 | Orthotic & Prosthetic Centre Pty Ltd OAPL Protective Face Mask with Earloops KN95 Mask 4PLY EAR LOOP [Batch number: 202004-9] | TGA |
| 05 Dec 2022 | Mun Global Sdn Bhd PrimeOn Artemis Level 2 Procedure Face Mask w/Earloop - Yellow [Lot number: 2004-09] | TGA |
| 30 Nov 2022 | BSN 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] | TGA |
| 18 Aug 2022 | Xiantao 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] | TGA |
| 12 Jul 2022 | Canggu Medical Tech Co Ltd (Sponsored by PACIFIC HEALTH PTY LTD) Dochem Face Mask and Dochem Face Mask Type IIR [All Batches] | TGA |
| 14 Jun 2022 | Jiangsu Okam New Materials Ltd KN95/FFP2 Particulate Respirator Mask [Model 516W] | Health Canada |
| 06 Jun 2022 | Medical Mart Supplies Limited Alliance Earloop Procedure Mask [Lot or serial number: Y591676; Model or catalog number: P703020] | Health Canada |
| 26 May 2022 | BUNZL Australasia N95 Particulate Respirator N95 FT-N058 [All batches] | TGA |
| 10 May 2022 | Thai 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] | TGA |
| 03 May 2022 | Mediquip Pty Ltd Gemini Dispoable Surgical Masks [Batch number: 2020072801; Expiry date: 28/07/2022] | TGA |
| 03 May 2022 | Purist Australian Purist Australian - Mask, medical single use [Batch number: 202003015; Production Date: 17/04/2020] | TGA |
| 06 Apr 2022 | Omni-Tel Pty Ltd MA-KN95-WOO [Batch numbers: QU201 and QU202; Expiry date: 05/2022 and 06/2022] | TGA |
| 30 Mar 2022 | MIRATRA 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] | TGA |
| 30 Mar 2022 | MIRATRA PTY LTD Moosh P2 Respirator Mask [Batch Number: 202004008; Expiry Date: 09/2022] | TGA |
| 09 Mar 2022 | Sichuan 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] | TGA |
| 09 Mar 2022 | BSN 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] | TGA |
| 08 Mar 2022 | Sentry Medical Pty Ltd OWear Mask with Earloop Fluid Protection IIR-120 mmHg [Batch number: 043020; Expiry date: 1/04/2025] | TGA |
| 08 Mar 2022 | Pacific Health Pty Ltd Premium Ear-loop-3 Layers Masks [Batch number: WHM-1050] | TGA |
| 08 Mar 2022 | Sentry Medical Pty Ltd OWear Procedure Mask – Earloop OMK001 Level 2 [Batch number: 12008810F, Expiry date: 31 August 2023] | TGA |
| 02 Mar 2022 | Arya Mobility Pty Ltd Ripe KN95 Nanofiber filtration Anti-Particulate Anti-virus Mask [Batch number: 2020-03-30] | TGA |
| 28 Feb 2022 | MCG ELECTRONICS PTY LTD Ripe Doctors KN95 Airway protection face mask | TGA |
| 21 Feb 2022 | O&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] | TGA |
| 21 Feb 2022 | Icon International Pty Ltd t/a Icon Medipharm 3 PLY DISPOSABLE SURGICAL FACE MASK [Batch number: AL091, Expiry date: 1/3/2025] | TGA |
| 15 Feb 2022 | Optimed Technologies Pty Ltd Veisha KN95 Mask [Batch number: 20040716] | TGA |
| 11 Feb 2022 | Southmedic Inc. Clearchoice Foam Face Shields [W84856, W85334, W85588, W85001; SMI3610, SMI3611] | Health Canada |
| 04 Feb 2022 | Care 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.] | TGA |
| 04 Feb 2022 | priMED 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 | TGA |
| 04 Feb 2022 | Winner Medical Co Ltd (Sponsored by Healthscope Operations PTY LTD) Particulate Respirator FFP2 NR [Batch number: 200519; Expiry date: 31/05/2023] | TGA |
| 04 Feb 2022 | Healthy 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] | Health Canada |
| 31 Jan 2022 | Qingdao Santec International Trade Co Ltd (sponsored by Erskine Products Pty Ltd) Piksters Shield Face Masks Level 3 [Batch number: SAN29904A] | TGA |
| 31 Jan 2022 | St John Ambulance Australia Inc St John Respirator Mask [Batch number: 20200501S0002; Expiry date: 10 May 2023] | TGA |
| 21 Jan 2022 | A Barcs & Co Nominees Pty Ltd Foldable Protective Earloop Mask KN95 | TGA |
| 11 Jan 2022 | Bio Protect Bio Protect Disposable Surgical Face Mask 3 Ply with Earloop Level 2 | TGA |
| 10 Jan 2022 | Mediquip Pty Ltd Gemini KN95 Protective Medical Masks [Batch Number: CY-20200519-1; Expiry Date: 19/05/2022] | TGA |
Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below.
* 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