Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 19, 2014
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
American Medical Systems, Inc. recalled AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 7… - a moderate-severity action.
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 7… was recalled by American Medical Systems, Inc. in November 19, 2014. Reason: AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accesso…. Check the official notice for the remedy. Verify recall #Z-0209-2015 with the FDA Devices before acting.
The recall
American Medical Systems, Inc. issued this moderate-severity FDA Devices recall-AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accesso….
- Moderate
- severity level
- Class II
- classification
- November 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0209-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0209-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on October 10, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. American Medical Systems, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 184 (110 US, 74 OUS).
The documented reason for this recall is: AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supp… Distribution data in the federal record shows the product reached: Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
184 (110 US, 74 OUS)
Related Recalls
6
3 from same agency
Product description
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
Reason for recall
AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0209-2015 |
| Date reported | November 19, 2014 |
| Date initiated | October 10, 2014 |
| Recalling firm | American Medical Systems, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 184 (110 US, 74 OUS) |
| Distribution | Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, G… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0209-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.. Recalled by American Medical Systems, Inc.. Units affected: 184 (110 US, 74 OUS).
Why was this product recalled? ▼
AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0209-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0209-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.