Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 25, 2019
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod 10888628005587 NATRELLE Sty 10-390 Rstrl Sizer Gel Mod 1088862800559
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Allergan PLC recalled NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (r… - a low-severity action.
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (r… was recalled by Allergan PLC in December 25, 2019. Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured…. Check the official notice for the remedy. Verify recall #Z-0702-2020 with the FDA Devices before acting.
The recall
Allergan PLC issued this low-severity FDA Devices recall-The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured….
- Low
- severity level
- Class III
- classification
- December 25, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0702-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0702-2020) was formally reported on December 25, 2019, with the manufacturer initiating the action on November 6, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Allergan PLC is listed as the recalling firm, operating out of Irvine, CA. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data ch… Distribution data in the federal record shows the product reached: US:AL, AR,AZ,CA,CO,DC,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
0 from same agency
Product description
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod 10888628005587 NATRELLE Sty 10-390 Rstrl Sizer Gel Mod 10888628005594 NATRELLE Sty 10-420 Rstrl Sizer Gel Mod 10888628005600 NATRELLE Sty 10-450 Rstrl Sizer Gel Mod 10888628005617 NATRELLE Sty 10-480 Rstrl Sizer Gel Mod 10888628005624 NATRELLE Sty 10-510 Rstrl Sizer Gel Mod 10888628005631 NATRELLE Sty 10-700 Rstrl Sizer Gel Mod 10888628005679 NATRELLE Sty 10-750 Rstrl Sizer Gel Mod 10888628005686 NATRELLE Sty 10-800 Rstrl Sizer Gel Mod 10888628005693 Style 15/UDI: NATRELLE Sty 15-304 Rstrl Sizer Gel Mid 10888628005778 NATRELLE Sty 15-339 Rstrl Sizer Gel Mid 10888628005785 NATRELLE Sty 15-371 Rstrl Sizer Gel Mid 10888628005792 NATRELLE Sty 15-397 Rstrl Sizer Gel Mid 10888628005808 NATRELLE Sty 15-421 Rstrl Sizer Gel Mid 10888628005815 NATRELLE Sty 15-457 Rstrl Sizer Gel Mid 10888628005822 NATRELLE Sty 15-492 Rstrl Sizer Gel Mid 10888628005839 NATRELLE Sty 15-533 Rstrl Sizer Gel Mid 10888628005846 NATRELLE Sty 15-575 Rstrl Sizer Gel Mid 10888628005853 NATRELLE Sty 15-616 Rstrl Sizer Gel Mid 10888628005860 Style 20/UDI: NATRELLE Sty 20-350 Rstrl Sizer Gel High 10888628006003 NATRELLE Sty 20-700 Rstrl Sizer Gel High 10888628006102 NATRELLE Sty 20-750 Rstrl Sizer Gel High 10888628006119 Inspira X (responsive Gel)/UDI: Natrelle Inspira X-Full 205cc Sizer (US) 10888628009431 Natrelle Inspira X-Full 225cc Sizer (US) 10888628009448 Natrelle Inspira X-Full 255cc Sizer (US) 10888628009455 Natrelle Inspira X-Full 285cc Sizer (US) 10888628009462 Natrelle Inspira X-Full 310cc Sizer (US) 10888628009479 Natrelle Inspira X-Full 340cc Sizer (US) 10888628009486 Natrelle Inspira X-Full 375cc Sizer (US) 10888628009493 Natrelle Inspira X-Full 400cc Sizer (US) 10888628009509 Natrelle Inspira X-Full 420cc Sizer (US) 10888628009516 Natrelle Inspira X-Full 445cc Sizer (US) 10888628009523 Natrelle Inspira X-Full 470cc Sizer (US) 10888628009530 Natrelle Inspira X-Full 495cc Sizer (US) 10888628009547 Natrelle Inspira X-Full 525cc Sizer (US) 10888628009554 Natrelle Inspira X-Full 545cc Sizer (US) 10888628009561 Natrelle Inspira X-Full 560cc Sizer (US) 10888628009578 Natrelle Inspira X-Full 580cc Sizer (US) 10888628009585 Natrelle Inspira X-Full 615cc Sizer (US) 10888628009592 Natrelle Inspira X-Full 650cc Sizer (US) 10888628009608 Natrelle Inspira X-Full 700cc Sizer (US) 10888628009615 Natrelle Inspira X-Full 750cc Sizer (US) 10888628009622 Natrelle Inspira X-Full 800cc Sizer (US) 10888628009639 Inspira F (responsive Gel)/UDI: MSZ-F180 Natrelle Inspira FullProf 180cc Sizer US 10888628009226 MSZ-F200 Natrelle Inspira FullProf 200cc Sizer US 10888628009233 MSZ-F220 Natrelle Inspira FullProf 220cc Sizer US 10888628009240 MSZ-F240 Natrelle Inspira FullProf 240cc Sizer US 10888628009257 MSZ-F265 Natrelle Inspira FullProf 265cc Sizer US 10888628009264 MSZ-F295 Natrelle Inspira FullProf 295cc Sizer US 10888628009271 MSZ-F325 Natrelle Inspira FullProf 325cc Sizer US 10888628009288 MSZ-F335 Natrelle Inspira FullProf 335cc Sizer US 10888628009295 MSZ-F345 Natrelle Inspira FullProf 345cc Sizer US 10888628009301 MSZ-F365 Natrelle Inspira FullProf 365cc Sizer US 10888628009318 MSZ-F385 Natrelle Inspira FullProf 385cc Sizer US 10888628009325 MSZ-F415 Natrelle Inspira FullProf 415cc Sizer US 10888628009332 MSZ-F450 Natrelle Inspira FullProf 450cc Sizer US 10888628009349 MSZ-F485 Natrelle Inspira FullProf 485cc Sizer US 10888628009356 MSZ-F520 Natrelle Inspira FullProf 520cc Sizer US 10888628009363 MSZ-F560 Natrelle Inspira FullProf 560cc Sizer US 10888628009370 MSZ-F605 Natrelle
Reason for recall
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0702-2020 |
| Date reported | December 25, 2019 |
| Date initiated | November 6, 2019 |
| Recalling firm | Allergan PLC |
| Firm location | Irvine, CA |
| Affected scope | Not disclosed |
| Distribution | US:AL, AR,AZ,CA,CO,DC,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY |
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-0702-2020) 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? ▼
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod 10888628005587 NATRELLE Sty 10-390 Rstrl Sizer Gel Mod 10888628005594 NATRELLE Sty 10-420 Rstrl Sizer Gel Mod 10888628005600 NATRELLE Sty 10-450 Rstrl Sizer Gel Mod 10888628005617 NATRELLE Sty 10-480 Rstrl Sizer Gel Mod 10888628005624 NATRELLE Sty 10-510 Rstrl Sizer Gel Mod 10888628005631 NATRELLE Sty 10-700 Rstrl Sizer Gel Mod 10888628005679 NATRELLE Sty 10-750 Rstrl Sizer Gel Mod 10888628005686 NATRELLE Sty 10-800 Rstrl Sizer Gel Mod 10888628005693 Style 15/UDI: NATRELLE Sty 15-304 Rstrl Sizer Gel Mid 10888628005778 NATRELLE Sty 15-339 Rstrl Sizer Gel Mid 10888628005785 NATRELLE Sty 15-371 Rstrl Sizer Gel Mid 10888628005792 NATRELLE Sty 15-397 Rstrl Sizer Gel Mid 10888628005808 NATRELLE Sty 15-421 Rstrl Sizer Gel Mid 10888628005815 NATRELLE Sty 15-457 Rstrl Sizer Gel Mid 10888628005822 NATRELLE Sty 15-492 Rstrl Sizer Gel Mid 10888628005839 NATRELLE Sty 15-533 Rstrl Sizer Gel Mid 10888628005846 NATRELLE Sty 15-575 Rstrl Sizer Gel Mid 10888628005853 NATRELLE Sty 15-616 Rstrl Sizer Gel Mid 10888628005860 Style 20/UDI: NATRELLE Sty 20-350 Rstrl Sizer Gel High 10888628006003 NATRELLE Sty 20-700 Rstrl Sizer Gel High 10888628006102 NATRELLE Sty 20-750 Rstrl Sizer Gel High 10888628006119 Inspira X (responsive Gel)/UDI: Natrelle Inspira X-Full 205cc Sizer (US) 10888628009431 Natrelle Inspira X-Full 225cc Sizer (US) 10888628009448 Natrelle Inspira X-Full 255cc Sizer (US) 10888628009455 Natrelle Inspira X-Full 285cc Sizer (US) 10888628009462 Natrelle Inspira X-Full 310cc Sizer (US) 10888628009479 Natrelle Inspira X-Full 340cc Sizer (US) 10888628009486 Natrelle Inspira X-Full 375cc Sizer (US) 10888628009493 Natrelle Inspira X-Full 400cc Sizer (US) 10888628009509 Natrelle Inspira X-Full 420cc Sizer (US) 10888628009516 Natrelle Inspira X-Full 445cc Sizer (US) 10888628009523 Natrelle Inspira X-Full 470cc Sizer (US) 10888628009530 Natrelle Inspira X-Full 495cc Sizer (US) 10888628009547 Natrelle Inspira X-Full 525cc Sizer (US) 10888628009554 Natrelle Inspira X-Full 545cc Sizer (US) 10888628009561 Natrelle Inspira X-Full 560cc Sizer (US) 10888628009578 Natrelle Inspira X-Full 580cc Sizer (US) 10888628009585 Natrelle Inspira X-Full 615cc Sizer (US) 10888628009592 Natrelle Inspira X-Full 650cc Sizer (US) 10888628009608 Natrelle Inspira X-Full 700cc Sizer (US) 10888628009615 Natrelle Inspira X-Full 750cc Sizer (US) 10888628009622 Natrelle Inspira X-Full 800cc Sizer (US) 10888628009639 Inspira F (responsive Gel)/UDI: MSZ-F180 Natrelle Inspira FullProf 180cc Sizer US 10888628009226 MSZ-F200 Natrelle Inspira FullProf 200cc Sizer US 10888628009233 MSZ-F220 Natrelle Inspira FullProf 220cc Sizer US 10888628009240 MSZ-F240 Natrelle Inspira FullProf 240cc Sizer US 10888628009257 MSZ-F265 Natrelle Inspira FullProf 265cc Sizer US 10888628009264 MSZ-F295 Natrelle Inspira FullProf 295cc Sizer US 10888628009271 MSZ-F325 Natrelle Inspira FullProf 325cc Sizer US 10888628009288 MSZ-F335 Natrelle Inspira FullProf 335cc Sizer US 10888628009295 MSZ-F345 Natrelle Inspira FullProf 345cc Sizer US 10888628009301 MSZ-F365 Natrelle Inspira FullProf 365cc Sizer US 10888628009318 MSZ-F385 Natrelle Inspira FullProf 385cc Sizer US 10888628009325 MSZ-F415 Natrelle Inspira FullProf 415cc Sizer US 10888628009332 MSZ-F450 Natrelle Inspira FullProf 450cc Sizer US 10888628009349 MSZ-F485 Natrelle Inspira FullProf 485cc Sizer US 10888628009356 MSZ-F520 Natrelle Inspira FullProf 520cc Sizer US 10888628009363 MSZ-F560 Natrelle Inspira FullProf 560cc Sizer US 10888628009370 MSZ-F605 Natrelle. Recalled by Allergan PLC.
Why was this product recalled? ▼
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2019. Severity: Low. Recall number: Z-0702-2020.
Where was the recalled product distributed? ▼
Distribution: US:AL, AR,AZ,CA,CO,DC,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0702-2020) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported December 25, 2019.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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.