In March 2024 the US Food and Drug Administration (FDA) issued a safety communication regarding their ongoing evaluation of quality and performance issues related to plastic syringes made in China, following their initial publication of this signal in November 2023.
The FDA continues to update this safety communication as new information becomes available, including details of manufacturers that are potentially affected. The FDA has identified non-compliances relating to quality system regulations for syringe products, quality issues and performance testing failures.
We have initiated a post-market review of the plastic syringes included in the Australian Register of Therapeutic Goods (ARTG) including those identified by the FDA.
For further information about ARTG entries which have been cancelled and/or suspended refer to the Outcomes and actions below.
Background
Generally, a syringe is used to inject fluid into, or withdraw fluid from, the body and can be used in a variety of clinical and home health settings.
Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.
The plastic syringes identified by the FDA may have quality issues, such as leaks, breakage, and other problems that occur after manufacturers made changes to syringe dimensions.
These quality issues may affect the performance and safety of the syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.
Overview
As part of the review, we required all sponsors of plastic syringe devices included in the ARTG, that are produced by the manufacturers identified in the signal, to provide information about their products, including:
- labelling information including the Instructions for Use (IFU)
- evidence to support design and construction according to safety requirements
- evidence of testing conducted by the manufacturer
- the manufacturer’s risk assessment and risk mitigation strategies
- all domestic and international incidents, adverse events, complaints, and any investigations undertaken, and corrective actions made as a result of these investigations.
Manufacturers of medical devices must ensure they consistently meet safety, performance, and quality requirements.
Plastic syringes produced by manufacturers other than those identified in the signal, are not subject to the current review.
Outcomes and actions
The post-market review is ongoing. We will update this page as new information becomes available.
As part of the review we have taken a range of actions, such as:
- Additional Conditions of Inclusion (COI) have been imposed on a number of ARTG entries. The conditions require sponsors to complete sampling using tightened inspection procedures and to provide ongoing reporting.
- Some ARTG entries have been suspended for a period of 6 months. This allows the sponsor and manufacturer time to address issues identified during the review.
ARTG-specific outcomes are shown in the table below.
While a device is suspended, it cannot be supplied in Australia during the period of the suspension.
Table 1 outlines the current status of the devices included in the review.
| ARTG | Sponsor | Manufacturer | Device name | Models | Status |
|---|---|---|---|---|---|
253034 | Becton Dickinson Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Syringe, general-purpose | Cancelled by Sponsor on 7/6/2024 | |
388510 | BMS Medical Supplies Pty Ltd | Yangzhou Medline Industry Co Ltd | General-purpose syringe/needle | Cancelled by Sponsor on 30/6/2024 | |
366734 | Clifford Hallam Healthcare Pty Ltd | Jiangsu Caina Medical Co Ltd | Insulin syringe, fixed-needle | 2550188 - INSULIN SYRINGE WNEEDLE 0.5ML 31G X 8MM ST SU 2550399 - INSULIN SYRINGE WITH NEEDLE 0.5ML 29G X 12.7MM ST SU | Ongoing review |
365470 | Clifford Hallam Healthcare Pty Ltd | Jiangsu Caina Medical Co Ltd | Syringe, hypodermic, metered-delivery | 2550161 - SYRINGE 60ML LUER LOCK TIP ST SU 2550250 - SYRINGE 1ML LUER LOCK TIP ST SU 2550268 - SYRINGE 10ML LUER LOCK TIP ST SU 2550276 - SYRINGE 20ML LUER LOCK TIP ST SU 2550284 - SYRINGE 3ML LUER LOCK TIP ST SU 2550292 - SYRINGE 5ML LUER LOCK TIP ST SU 2550305 - SYRINGE 1ML TB LUER SLIP TIP ST SU 2551746 - SYRINGE 3ML LUER SLIP TIP ST SU 2551754 - SYRINGE 5ML LUER SLIP TIP ST SU 2551762 - SYRINGE 10ML LUER SLIP TIP ST SU 2551771 - SYRINGE 20ML LUER SLIP TIP ST SU 2551789 - SYRINGE 10ML ECCENTRIC TIP ST SU 2551797 - SYRINGE 20ML ECCENTRIC TIP ST SU 2551800 - SYRINGE 50ML ECCENTRIC TIP ST SU 2551818 - SYRINGE 50ML CATHETER TIP ST SU | Ongoing review |
363731 | Denward Dell Pty Ltd | Jiangsu Caina Medical Co Ltd | Neuraxial syringe | Neuraxial syringe/NRFit syringe
| Suspended under s41GA(1)(b) from 5 March 2026 |
422473 | Firstar Australasia Pty Ltd | Jiangsu Shenli Medical Production Co Ltd | Syringe, general-purpose | Cancelled by Sponsor on 29/4/2024 | |
488487 | Imatec Medical Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Syringe, general-purpose | Suspended under s41GA(1)(b) from 23 March 2026 | |
361832 | Interpath Services Pty Ltd | Jiangsu Caina Medical Co Ltd | General-purpose syringe/needle | SNL12210 SNL12310 SNL12510 SPN102510 | Cancelled by Sponsor on 30/6/2025 |
408111 | Interpath Services Pty Ltd | Jiangsu Caina Medical Co Ltd | Insulin syringe, fixed-needle | Cancelled by Sponsor on 30/6/2025 | |
356863 | Interpath Services Pty Ltd | Jiangsu Caina Medical Co Ltd | Syringe, general-purpose | SN01001 SN01002 SN01004 SN01005 SN01006 SN01007 SN01008 SNO1003 SNO1003 | Cancelled by Sponsor on 30/6/2025 |
284736 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Oral/enteral syringe | 1ml 5ml | Suspended under s41GA(1)(b) from 18 December 2025 |
284737 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | General-purpose syringe/needle | 1ml 27G
| Suspended under s41GA(1)(b) from 18 December 2025 |
373421 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | General-purpose syringe/needle | Cancelled by Sponsor on 5/3/2025 | |
413350 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Insulin syringe, retractable-needle | Cancelled by Sponsor on 5/3/2025 | |
373978 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Syringe, general-purpose | Cancelled by Sponsor on 5/3/2025 | |
378992 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Syringe, general-purpose | 1ml 2ml 3ml 5ml 10ml 20ml 60ml | Suspended under s41GA(1)(b) from 18 December 2025 |
407955 | LC & Partners Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Syringe, general-purpose | 1ml 2ml 3ml 5ml 10ml 20ml 60ml | Suspended under s41GA(1)(b) from 18 December 2025 |
140057 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SANAngiophy - Angiographic kit | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140059 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SBAGeneral - Surgical procedure kit, general-purpose, single-use, medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140387 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SCVCardiolr - Surgical procedure kit, cardiothoracic, medicated, single-use | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140054 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SENENT - Surgical procedure kit, ENT, single-use, medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140055 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SLPLumPct - Medicine administration kit, percutaneous, non-medicated, single-use | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140058 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SNENeurgy - Surgical procedure kit, neurosurgical, single-use, medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
140056 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SOPOrthopdic - Surgical procedure kit, orthopaedic, single-use, medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
161685 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd | SOTUrology - Surgical procedure kit, urological, medicated, single-use | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
137395 | Medline International Two Australia Pty Ltd | Surgical procedure kit, general-purpose, single-use, non-medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. | |
136870 | Medline International Two Australia Pty Ltd | Medline Assembly Australia Pty Ltd
| Surgical procedure kit, general-purpose, single-use, non-medicated | CC83078 CC83080 CC83081 CC83082 CC83083 CC83084 CC83085 CC83086 CC83087 CC83088 P180001PP | Review complete As of March 2026, the plastic syringes in the procedure kits have been replaced with syringes from other manufacturers not identified in the signal, with no ongoing concerns identified. |
370616 | Medtronic Australasia Pty Ltd | Jiangsu Shenli Medical Production Co Ltd | Oral/enteral syringe, reusable | Cancelled by Sponsor on 7/6/2024 | |
281326 | Midmed Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Insulin syringe, fixed-needle | Cancelled by Sponsor on 18/6/2024 | |
297229 | Midmed Pty Ltd | Shanghai Kindly Enterprise Development Group Co Ltd | Oral/enteral syringe | Cancelled by Sponsor on 18/6/2024 | |
272214 | Multigate Medical Devices Pty Ltd | Multigate Co Ltd | Insulin syringe, retractable-needle | IV150129 IV158029 IV158129 IV150029 IV150127 | Ongoing review |
272195 | Multigate Medical Devices Pty Ltd | Multigate Co Ltd | Syringe, hypodermic, metered delivery, retractable needle | IV160113 IV170003 IV170005 IV170010 IV170020 | Ongoing review |
357017 | Multigate Medical Devices Pty Ltd | Jiangsu Caina Medical Co Ltd
| Neuraxial syringe | IV390003 IV390005 | Cancelled by Sponsor on 18/6/2024 |
393545 | Plus Medical Pty Ltd | Jiangsu Shenli Medical Production Co Ltd | Insulin syringe, fixed-needle | Cancelled by Sponsor 6/6/2024 | |
355735 | Smiths Medical Australasia Pty Ltd | Sol-Millennium Medical Inc | General-purpose syringe/needle | Cancelled by Sponsor on 2/9/2024 | |
355736 | Smiths Medical Australasia Pty Ltd | Sol-Millennium Medical Inc | Syringe, general-purpose | Cancelled by Sponsor on 2/9/2024 | |
405813 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | General-purpose syringe/needle | ATS004 ATS002 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328615 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | General-purpose syringe/needle | 12310SN 12315SN 12338SN 12510SN 12515SN 12558SN 12705SN 13005SN 181023L 1810258L 182025S 181027S 181025S 1831815B 1832010 1832015 1832110 1832115 1832210 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328616 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Syringe hypodermic, metered delivery, retractable needle | 100072IM 100074IM 100075IM 100076IM 100077IM 100078IM 100079IM 100085IM 120006IM 120007IM 120008IM 140065IM 140072IM 140076IM 140077IM 160072IM 160076IM 160077IM 190072IM 120009IM | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328617 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Insulin syringe, fixed-needle | 1612712B 1612758B 1612812B 1612912B 1613012B 1613051 1613051B 161311564B 1613151 1613151B 1632912B 1633012B 1633051B 163311564B 1633151B 1652712B 1652812B 1652912B 1653051 1653051B 165311564B 1653151 1653151B 200002SG 200003SG 200017SG 200091SG 2331516SG 2531516SG | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328618 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | General-purpose syringe/needle | 180001 180011 P180001 P180001PP P180003 P180011LDS 180001T P180001PPBS P180011LDSBS P180003 P180003T P180003ST P180003BS P180003STBS P180005ST 180005 P180005T P180005BS P180005STBS P180010 C180010BS P180010ST P180010BS P180010T 180010ET 180010ETBS P180010BS P180020 P180020ET P180020ST P180020T 180020ETBS P180020BS P180030 P180030 P180030T P180060ET P180060 P180060T 180060ETBS P180060BS | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328619 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Insulin syringe, retractable-needle | 100002IM 100017IM 100020IM 100081IM 100089IM 100071IM | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328621 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Dispenser, medication, liquid | 20010OA 21001OC 21001OP 21005OA 21005OC 21005OP 21010OC 21010OP 21003OC 21003OA 21003OP 21020OP 21001OA 21020OCBA | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328622 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Syringe, irrigating, general-purpose | 180060CT 180100CT 180100CTBS 180060CTBS | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328623 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Tuberculin-allergy syringe/retractable-needle | 100040IM 100088IM 100034IM 100018IM 100070IM 100069IM 100019IM 100032IM 100090IM 100067IM 100082IM | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
328624 | SOL-Millennium Medical Pty Ltd - | Sol-Millennium Medical Inc | Tuberculin- allergy syringe/ needle, basic | 182025 181027 181023 181023T 181025 181026T 180527 181027T 181026IDBT 181027IDBT 181126IDBT | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
399394 | SOL-Millennium Medical Pty Ltd - | Sol-Millennium Medical Inc | General-purpose syringe/needle | P180003MP P180005MP P180010MP P180030MP P180060MP | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
386810 | SOL-Millennium Medical Pty Ltd | Sol-Millennium Medical Inc | Non-ISO80369-3-standardized oral syringe
| 1ml 21001GANSB 21001GCNSB 3ml 21003GANSB 21003GCNSB 5ml 21005GANSB 21005GCNSB 10ml 21010GANSB 21010GCNSB | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. |
Note
An ARTG entry may be cancelled in two ways:
(1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or
(2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.
Information for consumers
Updates on the post-market review will be published on this page as further information becomes available.
If any recall actions are undertaken, they will be published on our recall actions database, the System for Australian Recall Actions (SARA).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Information for healthcare professionals
Specific information about each ARTG entry can be found by searching the ARTG public summary with the ARTG number that is found on the above webpage.
If you have questions or concerns regarding ongoing use or maintenance of devices that have been cancelled or suspended from the ARTG, please contact the sponsor of the device directly.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products.
For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
Related links
Page history
Updated data table.
Updated data table.
Inclusion of the outcomes and actions section.
Original publication.
Updated data table.
Updated data table.
Inclusion of the outcomes and actions section.
Original publication.