Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29755 |
| Brand Name: | Gelita-Spon Standard Absorbable Gelatin Sponge |
| Model: | GM-GS-010, GM-GS-010-DP, GM-GS-060, GM-GS-110, GM-GS-210, GM-GS-265-4, GM-GS-310 |
| Affected: | T02018/1, T02019/1, T02024/2, T02026/1, T02029/1, T02037/2, T02044/1, T02045/1, T02046/1, T02050/1, T02051/1, T02054/2, T02071/1, T02075/2, T02081/1, T02081/2, T02083/1, T02091/2, T02095/1, T02095/2, T02098/1, T02100/2, T02107/1, T02365/1, T02368/1, |
| Software version: | T02274/1, T02276/1, T02282/1, T02282/3, T02298/2, T02299/1, T02302/1, T02311/2, T02311/3, T02319/2, T02321/1, T02336/2, T02351/2. |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Gelita Medical GmbH |
| Brand Name: | TBSS-Neuro: Gelita-Spon Anal-Vaginal Tampon (Absorbable Gelatin Sponge) |
| Model: | GM-GS-010, GM-GS-010-DP, GM-GS-060, GM-GS-110, GM-GS-210, GM-GS-265-4, GM-GS-310 |
| Affected: | T02018/1, T02019/1, T02024/2, T02026/1, T02029/1, T02037/2, T02044/1, T02045/1, T02046/1, T02050/1, T02051/1, T02054/2, T02071/1, T02075/2, T02081/1, T02081/2, T02083/1, T02091/2, T02095/1, T02095/2, T02098/1, T02100/2, T02107/1, T02365/1, T02368/1, |
| Software version: | T02274/1, T02276/1, T02282/1, T02282/3, T02298/2, T02299/1, T02302/1, T02311/2, T02311/3, T02319/2, T02321/1, T02336/2, T02351/2. |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Gelita Medical GmbH |
| Brand Name: | Gelita-Spon IR Sponge (Absorbable Gelatin Sponge) |
| Model: | GM-GS-010, GM-GS-010-DP, GM-GS-060, GM-GS-110, GM-GS-210, GM-GS-265-4, GM-GS-310 |
| Affected: | T02018/1, T02019/1, T02024/2, T02026/1, T02029/1, T02037/2, T02044/1, T02045/1, T02046/1, T02050/1, T02051/1, T02054/2, T02071/1, T02075/2, T02081/1, T02081/2, T02083/1, T02091/2, T02095/1, T02095/2, T02098/1, T02100/2, T02107/1, T02365/1, T02368/1, |
| Software version: | T02274/1, T02276/1, T02282/1, T02282/3, T02298/2, T02299/1, T02302/1, T02311/2, T02311/3, T02319/2, T02321/1, T02336/2, T02351/2. |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Gelita Medical GmbH |
| Brand Name: | Gelita-Spon Dental Cube (Absorbable Gelatin Sponge) |
| Model: | GM-GS-010, GM-GS-010-DP, GM-GS-060, GM-GS-110, GM-GS-210, GM-GS-265-4, GM-GS-310 |
| Affected: | T02018/1, T02019/1, T02024/2, T02026/1, T02029/1, T02037/2, T02044/1, T02045/1, T02046/1, T02050/1, T02051/1, T02054/2, T02071/1, T02075/2, T02081/1, T02081/2, T02083/1, T02091/2, T02095/1, T02095/2, T02098/1, T02100/2, T02107/1, T02365/1, T02368/1, |
| Software version: | T02274/1, T02276/1, T02282/1, T02282/3, T02298/2, T02299/1, T02302/1, T02311/2, T02311/3, T02319/2, T02321/1, T02336/2, T02351/2. |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Gelita Medical GmbH |
| Issue: | The manufacturer has identified through routine bioburden testing, higher than acceptable levels of Endotoxins were observed. The endotoxin concentration of the product in some samples has been measured above the limit. Since these outliers in testing cannot be reconciled at this time, the manufacturer, has decided to recall all products. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/7/2022 |
