ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach
ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential sterile barrier breach, which is a risk-of-harm product issue where no specific injuries or illnesses are reported in the source text, fitting the Moderate severity criteria for low-risk contamination or precautionary recalls.
Plain-English summary
ConvaTec, Inc. is recalling Forceps Blue, disposable, sterile forceps, due to a potential breach in the sterile barrier. The recall involves 24,822,068 devices total. These devices are intended for use during clinical procedures to grasp, manipulate, or remove debris and wound tissue.
An internal assessment of the packaging confirmed the potential for a breach in the sterile barrier. The affected products are distributed worldwide, including in the United States (Illinois, Michigan, Pennsylvania, and Wisconsin) and numerous international countries. Specific lot codes and product reference numbers are listed in the official recall documentation.
Healthcare facilities and consumers should stop using the affected forceps and contact ConvaTec, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forcep
- Manufacturer
- ConvaTec, Inc
- Affected units
- 24,822,068
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code/REF Number: 417389
- Lot Codes: 167069
- 168288
- 171981
- 176327
- 179936
- 182217
- 187735
- 225174
- 231247
- 231248
- 307362
- 307578
- 308189
- 318432
- 318433
- 318434
- 489868
- 489951
- 490747
Distribution
Part of a larger recall action
This product is one of 4 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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