CLASS II Device recall · Reported 21 Aug 2013 · FDA Enforcement Report
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped recalled
Fisher Scientific is recalling Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100, distributed nationwide in the US. The recall was initiated on 5 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1955-2013
- FDA event ID
- 65822
- Recalling firm
- Fisher Scientific, Pittsburgh, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2013
- FDA classified
- 12 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Masks, Gloves & PPE
Timeline
| 5 Jun 2013 | Recall initiated by company | |
| 12 Aug 2013 | Classified by FDA | +68 days |
| 21 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.
Where it was distributed
Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
Which lots are affected?
Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.
Where was it sold?
Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fisher Scientific
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution recalled | Fisher Scientific | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v recalled | Fisher Scientific | Manufacturing (CGMP) Deviations | Nationwide |
| Device | CLASS II | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped recalled | Fisher Scientific | Foreign Material | Nationwide |
Other Masks, Gloves & PPE recalls
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|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |