Which CoolSculpting Cup Is Recalled, Elite, or Unknown?

Which cup is on the machine?

For a labeled hypothetical CoolSculpting visit, classify the cup actually on the machine. Consent forms and brochures often say only CoolSculpting. That trade name is not the applicator. Ask for the name printed on the cup or console, plus any REF, UDI, or 510(k) number, then place that one cup in one of four identities. The worked rows below are hypothetical identity checks. They are not a real patient, not a finding of paradoxical adipose hyperplasia (PAH), and not a census of what clinics still mount.

• Event 90331 parallel-plate (bucket 1). A cup named CoolCore, CoolCurve, CoolCurve+, CoolMax, or CoolFit in FDA Class 2 recall Event 90331. The five product records are Z-1347-2022 CoolCore REF BRZ-AP1-063-000; Z-1348-2022 CoolCurve BRZ-AP1-062-000; Z-1349-2022 CoolCurve+ BRZ-AP1-064-000; Z-1346-2022 CoolMax BRZ-AP1-080-000; and Z-1350-2022 CoolFit BRZ-AP1-066-000. All five list 510(k) K181740 and product code OOK. Zeltiq Aesthetics initiated the action on 9 June 2022; FDA created the records on 11 July 2022. The customer letter told clinics to discontinue and return those parallel-plate applicators because of an increased paradoxical-hyperplasia (PH/PAH) complaint rate in the 2019–2021 timeframe. As retrieved 14 September 2026, each record still shows Recall Status Open, Classified. That status is a database field, not proof that the cup in this room is one of the five, and not a remaining-stock count.

• CoolSculpting Elite (bucket 2). A cup named as an Elite-family applicator under a different 510(k), K212707 (letter 5 November 2021), whose predicate is K193566, not K181740. The K212707 comparison table lists C80, C120, C150, C240, F125, F165, and S150. 21 CFR 807.97 says a substantial-equivalence determination does not denote official approval. Elite clearance is named-device identity for this bucket. It is not a PAH-rate finding and not proof the cup in the room is not a recalled parallel-plate applicator.

• Named CoolAdvantage, CoolMini, or CoolSmooth family. Zeltiq’s Urgent Field Safety Notice FSCA-22-001-CS says the 2022 discontinuation and recall does not affect control units; cooling-cup applicators CoolMini, CoolAdvantage, CoolAdvantage Petite, and CoolAdvantage Plus; surface applicators CoolSmooth and CoolSmooth Pro; or the CoolSculpting Elite system and associated Elite applicators. A cup printed CoolAdvantage, CoolMini, or CoolSmooth is therefore outside Event 90331’s five REFs. It is also not an Elite identity merely because it was not recalled. Record that trade name. Do not collapse it into “FDA-cleared CoolSculpting” or into unknown.

• Unnamed or unknown. If the cup has no readable trade name, REF, or 510(k), the honest mark is unknown. A leftover package session, a different room’s Elite brochure, or the words “fat-freezing” do not fill those fields. Delay the cycle until the cup is identified; this page does not choose a treatment or a refund.

Identity worksheet: name, REF, 510(k), and unknown fields

Classifying an applicator requires the physical cup, the console readout if one is shown, or the IFU—not reception-area branding. 21 CFR 807.92 requires a 510(k) summary to identify a device by trade or proprietary name, common name, and classification name if known, and to state intended use, including the patient population where appropriate. Moving a remaining package session onto an unnamed cup, a recalled parallel-plate applicator, or an Elite applicator is therefore a change in named-applicator identity, not continuation of a generic CoolSculpting label. Sharing product code OOK and 21 CFR 878.4340 does not make two cups the same 510(k) or the same recall identity.

When filling this worksheet, record what can be read from the cup, console, or IFU. Do not assume a match from a brochure. Four checkpoints:

• Read the housing. Use the trade name molded, printed, or labeled on the cup. Do not rely on “our standard abdominal head” or a counter brochure. The name must be one of the manufacturer names above, or it stays unknown.

• Match the catalog REF or UDI, if present. Event 90331 identity is the Product/REF pair: BRZ-AP1-063-000, BRZ-AP1-062-000, BRZ-AP1-064-000, BRZ-AP1-080-000, or BRZ-AP1-066-000, with the public UDI-DI values 00816417020179, 00816417021008, 00816417020193, 00816417020230, and 00816417020216. A missing REF is unknown, not a match. Health Canada’s Type II recall lists the same five catalog numbers, all lots; that Canadian listing does not replace Event 90331 as the U.S. identity.

• Record any console or IFU name as a separate field. If a screen or IFU shows a model name, write it down. A displayed name is evidence of what the clinic claims is attached. It is not, by itself, a REF match, a 510(k) sticker, or proof against component substitution.

• Leave blanks blank. If the REF, UDI, or 510(k) cannot be read, mark unknown. 21 CFR 878.4340 classifies the whole contact-cooling aesthetic class; sharing OOK does not convert an unlabeled cup into K212707 or into “not recalled.”

The five parallel-plate cups FDA told clinics to return

On 9 June 2022, Zeltiq Aesthetics, Inc. initiated a manufacturer Class 2 correction/removal of named parallel-plate vacuum applicators. FDA posted the action under Recall Event ID 90331 on 11 July 2022 as five product records, all under product code OOK and 510(k) K181740. K181740 is the ZELTIQ CoolSculpting System letter dated 29 August 2018, regulation 21 CFR 878.4340, Class II, decision substantially equivalent. That 510(k) is the named-device identity attached to the recalled cups. It is not a 510(k) for CoolSculpting Elite, and a substantial-equivalence letter is not official FDA approval.

According to the FDA Action field on those records, the recalling firm started sending an URGENT: MEDICAL DEVICE RECALL letter via FedEx Overnight on 9 June 2022 telling customers to discontinue and return all CoolSculpting Parallel Plate Applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to an increase in the rate of complaints for paradoxical hyperplasia (PH), also referred to as paradoxical adipose hyperplasia (PAH), during the 2019 to 2021 timeframe. Manufacturer reason for recall is voluntary discontinuation and removal of parallel-plate applicators because of that increased complaint rate. Customers were told to discontinue further use, quarantine, count, and return the affected applicators. Those instructions are a recall-identity field for the named cups. They are not a diagnosis of PAH for a person sitting in a chair, not a finding that an unnamed cup is recalled, and not operating instructions for a treatment cycle.

“Parallel-plate” on these records is an applicator-identity label for the five named vacuum cups, not a finding that this visit will produce PAH. The FDA and Zeltiq reason for recall is the increased PH/PAH complaint rate in 2019–2021, not a room-level diagnosis and not a leftover-cup census. Do not treat Event 90331 as proof that a hypothetical patient has PAH, and do not treat Elite 510(k) clearance as a lower-PAH result.

On the Z-1350-2022 record, the Product field is CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000, UDI-DI 00816417020216. Some code-information lines are prefixed “CoolCurve” while listing BRZ-AP1-066-000. Use the Product/REF pair as the identity. That prefix is not proof that CoolFit is CoolCurve.

Elite is a different 510(k), not FDA approval

CoolSculpting Elite System K212707, letter dated 5 November 2021, is a different 510(k) from K181740. Trade name is CoolSculpting Elite System; common name skin cooling device; classification name contact cooling system for aesthetic use; Class II, 21 CFR 878.4340; product code OOK; predicate ZELTIQ CoolSculpting System K193566, not K181740. The 510(k) summary describes a control unit, detachable applicators, and accessories. The Elite user manual lists two applicator connector ports that can operate independently. K212707 states that applicator heating and cooling technology and method remain unchanged from the predicate. Dual ports and a new 510(k) number are identity facts. They are not a PAH-rate comparison with K181740.

The K212707 comparison table names seven compatible Elite applicators: C150, C120, C240, C80, F125, F165, and S150. The AbbVie CoolSculpting Elite System user manual also names Curve 80 (C80), Curve 120 (C120), Curve C135 (C135), Curve 150 (C150), Curve 240 (C240), plus flat and surface models used with the Elite system. C135 appears in that manual and does not appear in K212707’s comparison table. If the cup says C135, record the manufacturer name and mark the 510(k) match unknown unless a later public 510(k) is produced. The manual is cited only for applicator names. Cycle temperatures, durations, gel-trap steps, and cleaning steps are not reproduced here.

• Curve series named on K212707: C80, C120, C150, and C240. If the printed name is one of those four, that is an Elite-family name match to K212707, not a REF match and not FDA approval.

• Flat series named on K212707: F125 and F165. F165 is not CoolFit BRZ-AP1-066-000 and is not CoolAdvantage Fit.

• Surface applicator named on K212707: S150. CoolSmooth and CoolSmooth Pro are the FSCA-excluded surface family on the legacy system, not automatically S150.

Under 21 CFR 878.4340, a contact cooling system for aesthetic use is a cooling pad associated with a vacuum or mechanical massager intended for disruption of adipocyte cells for non-invasive aesthetic use, Class II with special controls. Indications for use on K212707 include cold-assisted lipolysis of listed body areas in stated BMI ranges: BMI of 30 or less for upper arm, bra fat, back fat, banana roll, thigh, abdomen, and flank; BMI up to 46.2 for submental and submandibular areas; plus language affecting the appearance of visible fat bulges in those areas and additional thermal-therapy language on Form FDA 3881. Those are labeled indications on the Elite 510(k). They do not identify the cup in the room, and classification as OOK does not make two cups the same 510(k) or the same recall identity.

Clearance under K212707 also does not mean PAH reports exist only for first-generation parallel-plate cups. A 2025 systematic review in Aesthetic Surgery Journal Open Forum (PMC12662051) tabulated published PAH cases attributed to first-generation CoolSculpting or Zeltiq-branded applicators, to the CoolAdvantage line, and to an isolated third-generation CoolSculpting Elite platform case. That literature is a reason not to treat Elite 510(k) clearance as a PAH-rate finding. It is not this worksheet’s incidence table, not a ranking, and not a census of cups currently mounted. Manufacturer PH frequency sentences on FSCA-22-001-CS stay in the source notice; they are not converted here into incidence for this visit.

CoolFit, CoolAdvantage Fit, and unnamed 'fat-freezing' cups

The word Fit is not a unique identity. Three different names collide in clinic speech:

• CoolFit, REF BRZ-AP1-066-000. First-generation parallel-plate cup on Event 90331, record Z-1350-2022, 510(k) K181740. The 9 June 2022 manufacturer letter told customers to discontinue and return it. That is a recall-identity field, not a PAH diagnosis.

• CoolAdvantage Fit. A CoolAdvantage-family name. FSCA-22-001-CS excludes CoolAdvantage from the 2022 return. K212707 describes Elite F165 as updated from the CoolAdvantage applicator with Fit contour (CoolAdvantage previously cleared in K162050). CoolAdvantage Fit is not CoolFit and is not Elite F165.

• Elite flat applicators F125 and F165. Named on K212707 for the Elite system. They are bucket 2 only when the printed name is actually F125 or F165 (or the matching Elite manual name) and the 510(k) story produced is K212707, not K181740.

Zeltiq’s Urgent Field Safety Notice FSCA-22-001-CS, hosted by the Danish Medicines Agency, names the same five parallel-plate part numbers (CoolMax BRZ-AP1-080-000, CoolCore BRZ-AP1-063-000, CoolCurve BRZ-AP1-062-000, CoolCurve+ BRZ-AP1-064-000, CoolFit BRZ-AP1-066-000). It states that the voluntary discontinuation and recall does not affect CoolSculpting control units; CoolMini, CoolAdvantage, CoolAdvantage Petite, and CoolAdvantage Plus; CoolSmooth and CoolSmooth Pro; or the CoolSculpting Elite system and associated Elite applicators. U.S. identity remains FDA Event 90331. Health Canada’s Type II recall (identification number RA-64287; start date 13 June 2022) lists the same five catalog numbers, all lots. Matching a REF to one of those five pairs supports bucket 1. A missing REF is unknown, not a match. Exclusion from the return letter is not a claim that excluded cups have zero PAH.

When a patient is presented with an unmarked applicator and told it is “standard fat freezing,” the verified identity is unknown. 21 CFR 807.92 is about what a 510(k) summary must name. It does not convert a clinic brochure into a 510(k) summary. An unnamed cup is unknown, not “FDA-cleared CoolSculpting.” This page does not give cycle settings for any cup, including Elite.

A different Elite recall is not this one

Search results that say “the CoolSculpting Elite was recalled” often collapse two FDA events. One is Event 90331, the 2022 parallel-plate PAH-complaint action. The other is a 2021 Elite software correction. They are different identities.

CoolSculpting Elite System Class 2 recall Z-2383-2021 under Event ID 88397 lists 510(k) K193566—not K212707 and not K181740. Product is Elite System software releases 2.0, 3.0, 3.0.1, and 3.0.2. Manufacturer reason is an incorrect error-messaging system that could fail to report a thermal event or could display unrelated error text that might lead to retreatment within 24 hours. The Action field states those bugs could result in cold-induced injury and second- or third-degree freeze burns. Quantity in commerce is 911 systems, updated 23 August 2021 to 1,105 systems. Recall Status is Terminated on 9 November 2023.

• Different event, different mechanism. Z-2383-2021 is a console software/error-messaging correction with freeze-burn risk language. Event 90331 is physical return of five parallel-plate cups because of an increased PH/PAH complaint rate. Termination of the software recall is not a PAH-rate finding.

• Different 510(k). Z-2383-2021 lists K193566. Event 90331 lists K181740. Elite System K212707 is a later Elite clearance. Sharing product code OOK does not merge the records.

• Terminated versus Open. Z-2383-2021 is Terminated (9 November 2023). Event 90331 product records remain Open, Classified as of 14 September 2026. Termination of one recall is not proof the cup in the room is Elite, and Open status is not a count of cups in a given clinic.

Attorney and clinic pages that say “the CoolSculpting Elite recall” without naming Event 90331 versus Event 88397 are collapsing two identities. Z-2383-2021 is not the 2022 parallel-plate PAH-complaint recall. This page does not instruct anyone how to run a software update or a treatment cycle.

What this page does not decide

A pre-treatment identity worksheet has limits. This page does not decide the following:

• No PAH diagnosis or incidence. Event 90331’s reason for recall is an increased complaint rate, not a finding that a hypothetical patient has or will get PAH. For signs, published incidence discussions, and correction options, see the separate PAH article linked below. Do not import that encyclopedia into this cup-identity job.

• No leftover-cup census. Quantity in commerce and Open status are FDA record fields as of 14 September 2026. No dated, de-identified sample of clinic applicator inventories was used. Public recall and 510(k) records are sufficient for identity rules, not for a prevalence claim about which cups clinics still mount.

• No cycle, temperature, or gel-pad instructions. The Elite user manual contains those steps. They are not copied here. Form FDA 3881 on K181740 and K212707 marks prescription use; that labeling fact is not an operator protocol in this article.

• No refund rights or typical mix. Whether a leftover package session can be moved to a different named cup, and whether a refund is owed, depends on the clinic contract and facts this page does not have. Hypothetical rows are not typical mix.

For readers exploring related clinical, economic, and regulatory questions, AestheticMedGuide maintains dedicated, evidence-led analyses across the aesthetic device landscape:

• Review clinical diagnostic criteria, histological findings, and surgical management options in our comprehensive guide on CoolSculpting PAH risk and complications.

• Analyze postmarket medical device reporting patterns and voluntary incident tracking in our investigation of CoolSculpting adverse events in the FDA MAUDE database.

• Examine how aesthetic practices calculate consumable card costs, cycle quotas, and capital depreciation in our guide to CoolSculpting applicator utilization economics.

• Learn how to audit manufacturer 510(k) summary filings and distinguish clearance from marketing claims in our tutorial on how to verify aesthetic device FDA clearances.

• Compare non-invasive cryolipolysis outcomes against injectable adipocytolytic alternatives in our clinical review of Kybella vs CoolSculpting for submental fullness.

• Understand broader medical device oversight and national recall enforcement patterns in our report on aesthetic device recalls in the FDA database.

• Capture device identifiers at the visit, including what clinics are not required to invent, in how to request treatment records, lot numbers, and device settings.

• Read clearance language against marketing wrappers in FDA 510(k) clearance for aesthetic devices.

• For outcome evidence rather than cup identity, see does CoolSculpting work.

Sources

• U.S. Food and Drug Administration. Medical Device Recalls — Event ID 90331, CoolSculpting System parallel-plate applicators (Z-1346-2022 through Z-1350-2022). FDA CDRH Recall Database (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall The CoolSculpting System — Z-1348-2022 CoolCurve Vacuum Applicator (REF BRZ-AP1-062-000). FDA Enforcement Report Z-1348-2022 (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall The CoolSculpting System — Z-1346-2022 CoolMax Vacuum Applicator (REF BRZ-AP1-080-000). FDA Enforcement Report Z-1346-2022 (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall The CoolSculpting System — Z-1347-2022 CoolCore Vacuum Applicator (REF BRZ-AP1-063-000). FDA Enforcement Report Z-1347-2022 (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall The CoolSculpting System — Z-1349-2022 CoolCurve+ Vacuum Applicator (REF BRZ-AP1-064-000). FDA Enforcement Report Z-1349-2022 (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall The CoolSculpting System — Z-1350-2022 CoolFit Vacuum Applicator (REF BRZ-AP1-066-000). FDA Enforcement Report Z-1350-2022 (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Premarket Notification 510(k) Decision Letter K181740: ZELTIQ CoolSculpting System. FDA CDRH 510(k) Database K181740 (August 29, 2018).

• U.S. Food and Drug Administration. Premarket Notification 510(k) Summary and Decision Letter K212707: CoolSculpting Elite System. FDA CDRH 510(k) Database K212707 (November 5, 2021).

• U.S. Food and Drug Administration. 21 CFR 807.97 — Misbranding by reference to premarket notification. Electronic Code of Federal Regulations (Accessed September 14, 2026).

• U.S. Food and Drug Administration. 21 CFR 807.92 — Content and format of a 510(k) summary. Electronic Code of Federal Regulations (Accessed September 14, 2026).

• U.S. Food and Drug Administration. 21 CFR 878.4340 — Contact cooling system for aesthetic use. Electronic Code of Federal Regulations (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Premarket Notification 510(k): Overview, Substantial Equivalence, and Regulatory Requirements. FDA Device Advice (Accessed September 14, 2026).

• U.S. Food and Drug Administration. Class 2 Device Recall CoolSculpting Elite System Software — Z-2383-2021 (Event ID 88397). FDA CDRH Recall Database Z-2383-2021 (Terminated November 9, 2023).

• ZELTIQ Aesthetics, Inc. / Danish Medicines Agency. Urgent Field Safety Notice FSCA-22-001-CS: Voluntary Recall and Discontinuation of CoolSculpting Parallel Plate Applicators. Danish Medicines Agency Safety Alert (June 2022).

• Health Canada. Coolsculpting System - Applicator - Vacuum: Type II medical-device recall (identification number RA-64287). Health Canada Recall Portal (June 13, 2022).

• AbbVie / Allergan Aesthetics. CoolSculpting Elite System User Manual (cited for applicator names only; cycle settings are not reproduced). RxAbbVie Device Documentation (Accessed September 14, 2026).

• Aesthetic Surgery Journal Open Forum. Incidence of Paradoxical Adipose Hyperplasia After Cryolipolysis: A Systematic Review and Meta-Analysis. PubMed Central PMC12662051 (2025).